Cochrane Database of Systematic Reviews

Orthodontic treatment for prominent upper front teeth (Class

II malocclusion) in children and adolescents (Review)

Batista KBSL, Thiruvenkatachari B, Harrison JE, O’Brien KD

Batista KBSL, Thiruvenkatachari B, Harrison JE, O’Brien KD.

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents.
Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: CD003452.
DOI: 10.1002/14651858.CD003452.pub4.

[Link]

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS

HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . 4
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . 19
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Analysis 1.1. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 1 Outcomes at
the end of phase I: functional versus observation. . . . . . . . . . . . . . . . . . . . . . . 84
Analysis 1.2. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 2 Incidence of
new incisal trauma during phase I treatment: functional versus observation. . . . . . . . . . . . . 85
Analysis 1.3. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 3 Outcomes at
the end of phase I: headgear versus observation. . . . . . . . . . . . . . . . . . . . . . . 86
Analysis 1.4. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 4 Incidence of
new incisal trauma during phase I treatment: headgear versus observation. . . . . . . . . . . . . . 87
Analysis 1.5. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 5 Outcomes at
the end of phase II: functional (2-phase) versus adolescent (1-phase) treatment. . . . . . . . . . . . 88
Analysis 1.6. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 6 Incidence of
new incisal trauma by the end of phase II treatment: functional (2-phase) versus adolescent (1-phase) treatment. 89
Analysis 1.7. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 7 Outcomes at
the end of phase II: headgear (2-phase) versus adolescent (1-phase) treatment. . . . . . . . . . . . . 90
Analysis 1.8. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome 8 Incidence of
new incisal trauma by the end of phase II treatment: headgear (2-phase) versus adolescent (1-phase) treatment. 91
Analysis 2.1. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional),
Outcome 1 Outcomes at the end of phase I: headgear versus functional. . . . . . . . . . . . . . . 92
Analysis 2.2. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional),
Outcome 2 Incidence of new incisal trauma during phase I treatment: headgear versus functional. . . . . . 93
Analysis 2.3. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional),
Outcome 3 Outcomes at the end of phase II: headgear versus functional. . . . . . . . . . . . . . 94
Analysis 2.4. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional),
Outcome 4 Incidence of new incisal trauma by the end of phase II treatment: headgear versus functional appliance. 95
Analysis 3.1. Comparison 3 Late orthodontic treatment: functional versus no treatment, Outcome 1 Final overjet. . 96
Analysis 3.2. Comparison 3 Late orthodontic treatment: functional versus no treatment, Outcome 2 Final ANB. . . 97
Analysis 4.1. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome
1 Twin Block versus other functional appliances (R-appliance, Bionator, Bite-Jumping appliance, Dynamax and
Herbst). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Analysis 4.2. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 2
Twin Block conventional versus other Twin Block modifications. . . . . . . . . . . . . . . . . 99
Analysis 4.3. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 3
Functional (Activator) versus prefabricated functional myobrace appliance (PFA). . . . . . . . . . . 99
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) i
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 4.4. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 4
Functional (Activator) versus fixed functional (FORSUS FRD EZ). . . . . . . . . . . . . . . . 100
Analysis 4.5. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 5
Fixed functional (FORSUS FRD) versus fixed functional with mini-implants (FMI). . . . . . . . . . 101
Analysis 4.6. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome
6 Fixed functional (FORSUS FRD) versus fixed functional with mini-implants (FMI) - patient satisfaction with
results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Analysis 4.7. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 7
R-appliance versus AIBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Analysis 4.8. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 8
Removable functional appliance versus fixed functional appliance. . . . . . . . . . . . . . . . . 103
Analysis 4.9. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 9
FORSUS versus intermaxillary elastics. . . . . . . . . . . . . . . . . . . . . . . . . . 104
Analysis 4.10. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 10
FMA stepwise (SWG) versus FMA single step (SSG). . . . . . . . . . . . . . . . . . . . . 105
Analysis 4.11. Comparison 4 Late orthodontic treatment: different types of appliances used for late treatment, Outcome 11
Harvold Activator versus Frankel function regulator. . . . . . . . . . . . . . . . . . . . . 106
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 111
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) ii
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Orthodontic treatment for prominent upper front teeth

(Class II malocclusion) in children and adolescents

Klaus BSL Batista1 , Badri Thiruvenkatachari2 , Jayne E Harrison3 , Kevin D O’Brien4

1 Department of Preventive and Public Dentistry, Rio de Janeiro State University, Rio de Janeiro, Brazil. 2 School of Dentistry, The
University of Manchester, Manchester, UK. 3Orthodontic Department, Liverpool University Dental Hospital, Liverpool, UK. 4Division
of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK

Contact address: Klaus BSL Batista, Department of Preventive and Public Dentistry, Rio de Janeiro State University, Boulevard 28 de
Setembro, 157, Vila Isabel, Rio de Janeiro, CEP: 20551-030, Brazil. klausbarretto@[Link].

Editorial group: Cochrane Oral Health Group.

Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 3, 2018.

Citation: Batista KBSL, Thiruvenkatachari B, Harrison JE, O’Brien KD. Orthodontic treatment for prominent upper front teeth
(Class II malocclusion) in children and adolescents. Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: CD003452. DOI:
10.1002/14651858.CD003452.pub4.

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
Prominent upper front teeth are a common problem affecting about a quarter of 12-year-old children in the UK. The condition
develops when permanent teeth erupt. These teeth are more likely to be injured and their appearance can cause significant distress.
Children are often referred to an orthodontist for treatment with dental braces to reduce the prominence of their teeth. If a child is
referred at a young age, the orthodontist is faced with the dilemma of whether to treat the patient early or to wait and provide treatment
in adolescence.
Objectives
To assess the effects of orthodontic treatment for prominent upper front teeth initiated when children are seven to 11 years old (’early
treatment’ in two phases) compared to in adolescence at around 12 to 16 years old (’late treatment’ in one phase); to assess the effects
of late treatment compared to no treatment; and to assess the effects of different types of orthodontic braces.
Search methods
Cochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 27 September
2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 8), MEDLINE Ovid
(1946 to 27 September 2017), and Embase Ovid (1980 to 27 September 2017). The US National Institutes of Health Ongoing
Trials Registry ([Link]) and the World Health Organization International Clinical Trials Registry Platform were searched
for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
Selection criteria
Randomised controlled trials of orthodontic treatments to correct prominent upper front teeth (Class II malocclusion) in children and
adolescents. We included trials that compared early treatment in children (two-phase) with any type of orthodontic braces (removable,
fixed, functional) or head-braces versus late treatment in adolescents (one-phase) with any type of orthodontic braces or head-braces,
and trials that compared any type of orthodontic braces or head-braces versus no treatment or another type of orthodontic brace or
appliance (where treatment started at a similar age in the intervention groups).
We excluded trials involving participants with a cleft lip or palate, or other craniofacial deformity/syndrome, and trials that recruited
patients who had previously received surgical treatment for their Class II malocclusion.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 1
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data collection and analysis
Review authors screened the search results, extracted data and assessed risk of bias independently. We used odds ratios (ORs) and 95%
confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used
the fixed-effect model for meta-analyses including two or three studies and the random-effects model for more than three studies.
Main results
We included 27 RCTs based on data from 1251 participants.
Three trials compared early treatment with a functional appliance versus late treatment for overjet, ANB and incisal trauma. After phase
one of early treatment (i.e. before the other group had received any intervention), there was a reduction in overjet and ANB reduction
favouring treatment with a functional appliance; however, when both groups had completed treatment, there was no difference between
groups in final overjet (MD 0.21, 95% CI −0.10 to 0.51, P = 0.18; 343 participants) (low-quality evidence) or ANB (MD −0.02, 95%
CI −0.47 to 0.43; 347 participants) (moderate-quality evidence). Early treatment with functional appliances reduced the incidence
of incisal trauma compared to late treatment (OR 0.56, 95% CI 0.33 to 0.95; 332 participants) (moderate-quality evidence). The
difference in the incidence of incisal trauma was clinically important with 30% (51/171) of participants reporting new trauma in the
late treatment group compared to only 19% (31/161) of participants who had received early treatment.
Two trials compared early treatment using headgear versus late treatment. After phase one of early treatment, headgear had reduced
overjet and ANB; however, when both groups had completed treatment, there was no evidence of a difference between groups in overjet
(MD −0.22, 95% CI −0.56 to 0.12; 238 participants) (low-quality evidence) or ANB (MD −0.27, 95% CI −0.80 to 0.26; 231
participants) (low-quality evidence). Early (two-phase) treatment with headgear reduced the incidence of incisal trauma (OR 0.45, 95%
CI 0.25 to 0.80; 237 participants) (low-quality evidence), with almost half the incidence of new incisal trauma (24/117) compared to
the late treatment group (44/120).
Seven trials compared late treatment with functional appliances versus no treatment. There was a reduction in final overjet with both
fixed functional appliances (MD −5.46 mm, 95% CI −6.63 to −4.28; 2 trials, 61 participants) and removable functional appliances
(MD −4.62, 95% CI -5.33 to -3.92; 3 trials, 122 participants) (low-quality evidence). There was no evidence of a difference in final
ANB between fixed functional appliances and no treatment (MD −0.53°, 95% CI −1.27 to −0.22; 3 trials, 89 participants) (low-
quality evidence), but removable functional appliances seemed to reduce ANB compared to no treatment (MD −2.37°, 95% CI -3.01
to -1.74; 2 trials, 99 participants) (low-quality evidence).
Six trials compared orthodontic treatment for adolescents with Twin Block versus other appliances and found no difference in overjet
(0.08 mm, 95% CI −0.60 to 0.76; 4 trials, 259 participants) (low-quality evidence). The reduction in ANB favoured treatment with
a Twin Block (−0.56°, 95% CI −0.96 to −0.16; 6 trials, 320 participants) (low-quality evidence).
Three trials compared orthodontic treatment for adolescents with removable functional appliances versus fixed functional appliances
and found a reduction in overjet in favour of fixed appliances (0.74, 95% CI 0.15 to 1.33; two trials, 154 participants) (low-quality
evidence), and a reduction in ANB in favour of removable appliances (−1.04°, 95% CI −1.60 to −0.49; 3 trials, 185 participants)
(low-quality evidence).
Authors’ conclusions
Evidence of low to moderate quality suggests that providing early orthodontic treatment for children with prominent upper front teeth
is more effective for reducing the incidence of incisal trauma than providing one course of orthodontic treatment in adolescence. There
appear to be no other advantages of providing early treatment when compared to late treatment. Low-quality evidence suggests that,
compared to no treatment, late treatment in adolescence with functional appliances, is effective for reducing the prominence of upper
front teeth.

PLAIN LANGUAGE SUMMARY

Orthodontic treatment for prominent upper front teeth in children
Review question
This review, carried out by authors working with Cochrane Oral Health , has been produced to assess the effects of orthodontic
treatment (treatment by dentists who specialise in the growth, function and position of teeth and jaws) for prominent upper front teeth
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 2
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
in children. The review looks at whether this treatment is best initiated at seven to 11 years old (early treatment in two phases), or in
adolescence, at around age 12 to 16 years (late treatment in one phase). The use of different types of braces was also assessed.
Background
Prominent (or sticking out) upper front teeth are a common problem in children around the world. For example, this condition affects
about a quarter of 12-year-old children in the UK. The correction of this condition is one of the most common treatments performed by
orthodontists (dentists who specialise in the growth, function and position of teeth and jaws). This condition develops when the child’s
permanent teeth erupt. Children are often referred to an orthodontist, for treatment with dental braces, to reduce the prominence of
the teeth. Prominent upper front teeth are more likely to be injured and their appearance can cause significant distress.
If a child is referred at a young age, the orthodontist is faced with the dilemma of whether to treat the patient early or to wait until the
child is older and provide treatment in adolescence.
In ’early treatment’, treatment is given in two phases: first at an early age (seven to 11 years old) and again in adolescence (around 12
to 16 years old). In ’late treatment’ (one phase), there is only one course of treatment in adolescence.
As well as the timing of treatment, this review also looked at the different types of braces used: removable, fixed, functional, or head-
braces.
Study characteristics
This review is based on 27 studies including 1251 participants. Participants were children and adolescents aged under 16 years who
had prominent upper front teeth (Class II Division 1 malocclusion). The evidence in this review is up to date as of 27 September 2017.
Key results
The evidence suggests that providing orthodontic early treatment to children with prominent upper front teeth reduces the incidence
of damage to upper incisor teeth significantly (middle four teeth at the top) as compared to treatment that is provided in one phase
in adolescence. There are no other advantages of providing a two-phase treatment (i.e. between age seven to 11 years and again in
adolescence) compared to treatment in one phase in adolescence.
The evidence also suggests that providing treatment with functional appliances for adolescents with prominent upper front teeth,
significantly reduces their prominence when compared to adolescents who did not receive any treatment. The studies did not suggest
that any particular appliance was better than any other for reducing teeth prominence.
Quality of the evidence
The overall quality of the evidence is low for most comparisons and outcomes, therefore further research is needed and may change the
findings.

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 3
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]

Early treatment (two- phase: phase one in childhood and phase two in adolescence) versus late treatment (one- phase in adolescence) with functional appliance

Patient or population: children and/ or adolescents (age ≤ 16 years) receiving orthodontic treatm ent to correct prom inent upper f ront teeth
Intervention: early treatm ent with f unctional appliance
Comparison: late treatm ent with f unctional appliance

Outcomes Illustrative comparative risks* (95% CI) Relative effect Number of participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)

Assumed risk Corresponding risk

Late treatment with Early treatment with

functional appliance functional appliance

Overjet (m m ) M ean f inal overjet M ean f inal overjet 0. 343 (3) ⊕⊕ The f unctional appli-
(sm aller value better) ranged across control 21 m m m ore (0.10 m m low23 ance reduced overjet
Follow-up at end of or- groups f rom 2.6 m m to less to 0.51 m m m ore) com pared to no treat-
thodontic treatm ent 4.3 m m m ent at the end of
the f irst phase of early
treatm ent (M D −4.17,
−4.61 to −3.73; 432
participants)

Incidence of incisal 298 per 1000 1 192 per 1000 (123 to OR 0.56 (0.33 to 0.95) 332 (3) ⊕⊕⊕
traum a 288) moderate 2
Follow-up at end of or-
thodontic treatm ent

ANB (°) M ean f inal ANB ranged M ean f inal ANB 0.02° 347 (3) ⊕⊕⊕ The f unctional appli-
Follow-up at end of or- across control groups less (0.47° less to 0.43° moderate 2 ance im proved ANB at
thodontic treatm ent f rom 3.7° to 4.0° m ore) the end of the f irst
phase of early treat-
m ent when com pared
with no treatm ent (M D
−0.89, −1.38 to −0.40;
419 participants)
4
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)

* The basis f or the assumed risk (e.g. the m edian control group risk across studies) is provided in f ootnotes. The corresponding risk (and its 95% CI) is based on the assum ed
risk in the com parison group and the relative effect of the intervention (and its 95% CI)

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our conf idence in the estim ate of ef f ect.
M oderate quality: Further research is likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and m ay change the estim ate.
Low quality: Further research is very likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and is likely to change the estim ate.
Very low quality: We are very uncertain about the estim ate.
1 Based on average in control groups
2
Downgraded as 2 of the 3 studies were at high risk of bias
3 Downgraded due to heterogeneity (Chi² = 5.23, degrees of f reedom (df ) = 2 (P value = 0.07); I² = 62%)
5
BACKGROUND and jaws from the back of the head. Treatment is usually carried
out either early (early treatment), when a mixture of baby and
adult teeth are present (around seven to 11 years of age) or later
Description of the condition (adolescent treatment) when all the adult teeth have come into the
mouth (around 12 to 16 years of age). In severe cases and some
Orthodontics is the branch of dentistry concerned with the growth
adults, orthodontic treatment may need to be combined with jaw
of the jaws and face, the development of the teeth and the way
surgery to correct the position of one or both jaws.
the teeth and jaws bite together. It also involves treatment of the
teeth and jaws when they are irregular or bite in an abnormal
way or both. There are many reasons why the teeth may not bite
together correctly. These include the position of the teeth, jaws,
lips, tongue, or cheeks; or may be due to heredity, a habit or the
Why it is important to do this review
way people breathe. The need for orthodontic treatment can be Cochrane Oral Health undertook an extensive prioritisation ex-
decided by looking at the effect any particular tooth position has ercise in 2014 to identify a core portfolio of titles that were the
on the life expectancy of the teeth, or the effect that the appearance most clinically important ones to maintain in the Cochrane Li-
of the teeth has on how people feel about themselves, or both brary (Worthington 2015). This review was identified as a priority
(Shaw 1991). title by the orthodontic expert panel (Cochrane OHG priority
Prominent upper front teeth (Class II malocclusion) may be due review portfolio).
to any combination of the jaw, tooth and lip position. The upper The correction of prominent upper front teeth is one of the most
jaw (maxilla) can be too far forward or, more usually, the lower common treatments performed by orthodontists. Even though we
jaw (mandible) is too far back. The upper front teeth (incisors) have several brace types to correct prominent upper front teeth,
may stick out if the lower lip catches behind them or due to a new braces are being introduced in the market to overcome the
habit (e.g. thumb sucking). This gives the patient an appearance drawbacks of previous ones and there is a need to establish the
that may be a target for teasing (Shaw 1980) and bullying (Seehra relative effectiveness of the different braces that can be used. It is
2011), which impacts on quality of life (Johal 2007; Silva 2016). very important that we identify the most effective type of brace to
When front teeth stick out (more than 3 mm to 5 mm), they are give the best available treatment.
two to three times more likely to be injured (Frujeri 2014; Nguyen
1999). Prominent upper front teeth (Class II malocclusion) is one
of the most common problems seen by orthodontists and affects
about a quarter of 12-year-old children in the UK (Holmes 1992).
However, there are racial differences: prominent upper front teeth
OBJECTIVES
(Class II malocclusion) are most common in whites of Northern
European origin and least common in black and oriental races To assess the effects of orthodontic treatment for prominent upper
and some Scandinavian populations (El-Mangoury 1990; Proffit front teeth initiated when children are seven to 11 years old (’early
1993; Silva 2001). treatment’ in two phases) compared to in adolescence when they
are around 12 to 16 years old (’late treatment’ in one phase); to
assess the effects of late treatment compared to no treatment; and
Description of the intervention to assess the effects of different types of orthodontic braces.
Several dental brace (orthodontic) treatments have been suggested
to correct prominent upper front teeth (Class II malocclusions).
Some treatments aim to move the upper front teeth backwards
METHODS
(with or without the extraction of teeth) whilst others aim to
modify the growth of the upper or lower jaw or both to reduce the
prominence of the upper front teeth. Treatment can involve the
use of one or more types of orthodontic brace.
Criteria for considering studies for this review

How the intervention might work

Types of studies
Some braces apply a force directly to the teeth and can either be
removed from the mouth or fixed to the teeth, with special glue, All randomised controlled trials of orthodontic treatments to cor-
during treatment. Other types of brace are attached, via the teeth, rect prominent upper front teeth (Class II, Division 1 malocclu-
to devices (headgear) that allow a force to be applied to the teeth sion).

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 6
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of participants trials and controlled clinical trials. There were no language, pub-
Children (seven to 11 years old) and adolescents (usually 12 to 16 lication year or publication status restrictions.
years old) receiving orthodontic treatment to correct prominent • Cochrane Oral Health’s Trials Register (searched 27
upper front teeth (Class II malocclusion). September 2017) (Appendix 1).
We excluded trials including participants with a cleft lip or palate or • Cochrane Central Register of Controlled Trials
both, or other craniofacial deformity/syndrome. We also excluded (CENTRAL; 2017, Issue 8) in the Cochrane Library (searched
trials that recruited patients who had previously received surgical 27 September 2017) (Appendix 2).
treatment for their Class II malocclusion. • MEDLINE Ovid (1946 to 27 September 2017) (Appendix
3).
• Embase Ovid (1980 to 27 September 2017) (Appendix 4).
Types of interventions
Subject strategies were modelled on the search strategy designed for
• Early treatment (two-phase) in childhood with any type of
MEDLINE Ovid. Where appropriate, they were combined with
orthodontic brace (removable, fixed, functional) or head-brace
subject strategy adaptations of the Highly Sensitive Search Strategy
compared with late treatment in adolescence (in one phase) with
designed by Cochrane for identifying randomised controlled trials
any type of orthodontic brace (removable, fixed, functional) or
and controlled clinical trials as described in the Cochrane Handbook
head-brace.
for Systematic Reviews of Interventions, Chapter 6 (Lefebvre 2011).
• Any type of orthodontic brace (removable, fixed,
functional) or head-brace compared with no treatment or
another type of orthodontic brace or appliance. For this Searching other resources
comparison, treatment should have been started in children of The following trial registries were searched for ongoing studies:
similar ages in both groups. • US National Institutes of Health Ongoing Trials Register (
[Link]; searched 29 September 2017) (Appendix 5).
Types of outcome measures • World Health Organization International Clinical Trials
Registry Platform ([Link]/trialsearch; searched 29
We recorded clinically important outcomes at the most common
September 2017) (Appendix 6).
endpoints that were reported. If we identified harms, these were
recorded and reported in descriptive terms. We handsearched the following journals.
• Seminars in Orthodontics (from 1995 to December 2006).
• Clinical Orthodontics and Research (from 1998 to December
Primary outcomes
2001).
• Prominence of the upper front teeth (overjet measured in • Orthodontics & Craniofacial Research (from 2001 to
millimetres or by any index of malocclusion). December 2006).
• Australian Orthodontic Journal (from 1956 to December
2006).
Secondary outcomes
• Relationship between upper and lower jaws measured, for We checked the bibliographies of the clinical trials that we iden-
example, by ANB angle. tified for references to trials published outside the handsearched
• Self-esteem and patient satisfaction. journals, including personal references. We contacted the first
• Any injury to the upper front teeth (i.e. incisal trauma). named authors of all trial reports in an attempt to identify un-
• Jaw joint problems. published studies and to obtain any further information about the
• Number of attendances required to complete treatment. trials.
• Harms such as health of the gums, damage to the teeth (e.g. We searched the reference lists of included studies and relevant
tooth decay). systematic reviews for further studies.
• Standard of orthodontic treatment. We did not perform a separate search for adverse effects of inter-
ventions used, we considered adverse effects described in included
studies only.
Search methods for identification of studies

Data collection and analysis

Electronic searches
Cochrane Oral Health’s Information Specialist conducted system-
atic searches of the following databases for randomised controlled Selection of studies

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 7
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Two review authors (KB and BT or BT and JH), independently For dichotomous outcomes, we expressed the estimates of effect of
and in duplicate, assessed the eligibility of all reports that were an intervention as odds ratios together with 95% confidence in-
identified by the search strategy as being potentially relevant to tervals (CIs). For continuous outcomes, we used mean differences,
the review. They were not blinded to author(s), institution or together with 95% CIs, to summarise the data for each group.
site of publication. Disagreements were resolved by discussion or
following clarification from authors.
Assessment of heterogeneity
The significance of any discrepancies in the estimates of the treat-
Data extraction and management ment effects from the different trials was assessed by means of
Cochrane’s test for heterogeneity and the I² statistic, which de-
Two review authors (KB and BT or BT and JH) extracted data (in-
scribes the percentage total variation across studies that is due to
dependently and in duplicate) using a specially designed data ex-
heterogeneity rather than chance.
traction form. We recorded the year of publication, interventions
assessed, outcomes, sample size and age of subjects. We grouped
the outcome data into those measured at the end of treatment Data synthesis
provided for young children and at the end of treatment provided We performed meta-analysis only if there were studies with similar
for adolescent children. comparisons that reported the same outcome measures. We com-
bined odds ratios for dichotomous data, and mean differences for
continuous data, using random-effects models if there were four
Assessment of risk of bias in included studies or more studies in the meta-analysis, and fixed-effect models if
This was conducted using the recommended approach for assess- there were up to three studies.
ing risk of bias in studies included in Cochrane Reviews (Higgins
2011). We used the two-part tool, addressing six specific domains Subgroup analysis and investigation of heterogeneity
(namely sequence generation; allocation concealment; blinding of
We assessed clinical heterogeneity by examining the types of par-
outcome assessors; incomplete outcome data; selective outcome
ticipants and interventions for all outcomes in each study.
reporting; and other bias). Each domain included one specific en-
try in a ’Risk of bias’ table. Within each entry, the first part of the
tool involved describing what was reported to have happened in Sensitivity analysis
the study. The second part of the tool involved assigning a judge- We had planned to undertake sensitivity analyses to examine the
ment relating to the risk of bias for that entry, either ’low risk’, effect of the study risk of bias assessment on the overall estimates of
’high risk’ or, where there was insufficient information on which effect. In addition, we planned to examine the effect of including
to base a judgement, ’unclear risk’. unpublished literature, but there were insufficient trials to under-
The risk of bias assessments were undertaken independently and take this.
in duplicate by two review authors (KB and BT or BT and JH) as
part of the data extraction process with assistance from Cochrane
Summarising findings
Oral Health when necessary.
After taking into account the additional information provided by We created ’Summary of findings’ (SoF) tables to record results of
the authors of the trials, we grouped studies into the following the main outcomes (overjet, incisal trauma and ANB) for the main
categories. comparisons: early treatment using a functional appliance versus
• Low risk of bias (plausible bias unlikely to seriously alter the late treatment; early treatment using headgear versus late treat-
results) if all key domains were assessed as low. ment; late treatment with functional appliances versus no treat-
• Unclear risk of bias (plausible bias that raises some doubt ment; late treatment with different appliances (two tables). We
about the results) if one or more key domains were assessed as assessed the quality of the evidence using GRADE.
unclear.
• High risk of bias (plausible bias that seriously weakens
confidence in the results) if one or more key domains were
assessed to be at high risk of bias. RESULTS

A ’Risk of bias’ table was completed for each included study and
results were presented graphically. Description of studies

Measures of treatment effect Results of the search

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 8
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
The initial review was published in 2007. Searches to date
(September 2017) have identified a total of 2319 records (910 af-
ter duplicates removed), of which we assessed 181 records in full
text. Of these 181 records, we excluded 104 articles and we con-
sidered a further 14 irrelevant. Twenty-seven trials (published in
63 papers) met the inclusion criteria. See Figure 1.

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 9
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 1. Study flow diagram

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 10
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Characteristics of the intervention
Included studies
All of the trials provided a clear description of the treatment pro-
See Characteristics of included studies table for details of included
tocols.
studies.
We classified the interventions for the treatment of Class II mal-
occlusion as follows.
Characteristics of the trial settings and investigators
Of the 27 included trials, seven were conducted in the Early treatment (two-phase) for Class II Division 1
United Kingdom (Banks 2004; Lee 2007; London 1998; malocclusion
Thiruvenkatachari 2010; UK (11-14) 2003; UK (Mixed) 2009; • There were three trials that compared early treatment (two-
Yaqoob 2012); three were carried out in North America (Florida phase) with late treatment (one-phase) (Florida 1998; North
1998; Ghafari 1998; North Carolina 2004); two were conducted Carolina 2004; UK (Mixed) 2009).
in China (Mao 1997; Jin 2015); one in New Zealand (New • Three trials compared two different types of appliances for
Zealand 2000); one in Australia (Bilgiç 2011); four in Turkey (Aras early treatment (Florida 1998; Ghafari 1998; North Carolina
2017a; Aras 2017b; Cura 1997; Baysal 2014); two in Iran (Jamilian 2004).
2011; Showkatbakhsh 2011); two in Syria (Alali 2014; Burhan
2015); one in Brazil (Cevidanes 2003); one in Italy (Martina In this group of trials, treatment of Class II division 1 malocclusion
2013); two in Egypt (Eissa 2017; Elkordy 2016); and one in Swe- started when participants were aged nine years and comprised two
den (Cirgi 2016). All trials had a parallel-group design. Five were treatment phases. In phase one, participants were randomised to
multicentre studies (Banks 2004; Thiruvenkatachari 2010; UK receive one of two types of appliance or to a control group that
(11-14) 2003; UK (Mixed) 2009; Cirgi 2016). Eleven of the received no early treatment. When phase one of the trials was
trials had more than one publication. Seven of the trials received completed, participants who had early treatment had a second
external funding. The providers and assessors were dental staff. phase of treatment, and participants who were in the no treatment
group had one single phase of adolescent treatment. Outcome
measures were compared between those who had received both
Characteristics of the participants early and late treatment and those who received late treatment
For the 27 trials included in the review, the results are based on only.
data from 1251 participants who presented with prominent upper
front teeth (Class II Division 1 malocclusion). The number of
Late treatment in adolescence (one-phase) for Class II
participants in each treatment or control group ranged from 12 to
Division 1 malocclusion
105.
Four trials provided treatment for children aged between 7 and • Nine trials compared functional appliances with no
11 years old (Florida 1998; Ghafari 1998; North Carolina 2004; treatment (Alali 2014; Baysal 2014; Cevidanes 2003; Cura 1997;
UK (Mixed) 2009). One trial provided treatment for children Eissa 2017; Elkordy 2016; Mao 1997; Martina 2013; New
who were 7 to 14 years old (Cirgi 2016). Two trials provided Zealand 2000). As Baysal 2014 did not randomise participants
treatment for children aged between 8 and 11 years (Mao 1997; to the ’no treatment’ arm, we did not include their results for the
Showkatbakhsh 2011). Three trials provided treatment for chil- functional versus no treatment comparison.
dren aged between 9 and 13 years old (Cevidanes 2003; Jamilian • Eighteen trials compared different types of appliances.
2011; Martina 2013). One trial provided treatment for children ◦ Twin Block appliances were compared with other
who were 10 to 13 years old (New Zealand 2000). Twenty provided types of appliances in eight trials (Baysal 2014; Burhan 2015;
treatment for children who were 10 to 15 years old (Alali 2014; Jamilian 2011; Jin 2015; Lee 2007; London 1998;
Aras 2017a; Aras 2017b; Banks 2004; Baysal 2014; Burhan 2015; Thiruvenkatachari 2010; UK (11-14) 2003).
Bilgiç 2011; Cura 1997; Eissa 2017; Elkordy 2016; Jin 2015; Lee ◦ Twin Block appliances were compared with various
2007; London 1998; Thiruvenkatachari 2010; UK (11-14) 2003; modifications to twin blocks in two trials (Banks 2004; Yaqoob
Yaqoob 2012). 2012).
Two of the trials had an active recruitment strategy that involved ◦ Andresen activator was compared with a prefabricated
screening school children and providing incentives, such as re- functional appliance in one trial (Cirgic 2016).
duced fees for participation (Florida 1998; North Carolina 2004). ◦ Forsus Fatigue Resistance Device was compared to
The percentage of participants lost to follow-up varied from 0% Forsus Fatigue Resistance Device and mini-implants in two trials
to 26%. (Eissa 2017; Elkordy 2016).

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 11
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 ◦ R-appliance was compared with Anterior Inclined Bite Sequence generation
Plate in one trial (Showkatbakhsh 2011). In 16 studies (Aras 2017a; Aras 2017b; Banks 2004; Baysal 2014;
◦ Removable functional appliances were compared to Burhan 2015; Eissa 2017; Elkordy 2016; Jamilian 2011; Jin
fixed functional appliances in three trials (Baysal 2014; Bilgiç 2015; Martina 2013; North Carolina 2004; Showkatbakhsh 2011;
2011; UK (11-14) 2003). Thiruvenkatachari 2010; UK (11-14) 2003; UK (Mixed) 2009;
◦ Forsus Fatigue Resistance Device was compared with Yaqoob 2012), the method of random sequence generation was
intermaxillary elastics in one trial (Aras 2017b). clearly described and these studies were assessed as being at low
◦ Functional mandibular advancer was compared for risk of bias for this domain. Ten of these studies used minimisation
stepwise versus single step advancement (Aras 2017a). software as a method of sequence generation (Aras 2017a; Aras
◦ Harvold Activator was compared with Frankel 2017b; Banks 2004; Burhan 2015; Eissa 2017; Elkordy 2016;
function regulator (New Zealand 2000) Martina 2013; Thiruvenkatachari 2010; UK (11-14) 2003; UK
(Mixed) 2009). One study used stratified block randomisation
(Yaqoob 2012), four studies used random number tables (Baysal
Outcome measures in the included studies
2014; Jamilian 2011; Jin 2015; Showkatbakhsh 2011) and one
The primary outcome measure was the prominence of the up- used Proc plan in SAS (North Carolina 2004). Nine studies did
per front teeth (overjet measured in millimetres or by any index not report on the method of random sequence generation and were
of malocclusion), and this was included in all studies. We also judged at unclear risk of bias (Alali 2014; Cevidanes 2003; Cirgi
measured the relationship between upper and lower jaws (ANB 2016; Cura 1997; Ghafari 1998; Lee 2007; London 1998; Mao
angle measured in degrees), self-esteem and patient satisfaction 1997; New Zealand 2000) . Two studies were judged to be at high
(measured using reported questionnaires), any injury to the upper risk of bias (Bilgiç 2011; Florida 1998). Florida 1998 reported an
front teeth, jaw joint problems, number of attendances required to inadequate method of randomisation, filling up the partially filled
complete treatment, harms to gums, damage to the teeth and the blocks in stratified block randomisation due to slow rate of entry.
Bilgiç 2011 reported that participants were selected and matched
standard of orthodontic treatment (measured using PAR scores
between groups according to the inclusion criteria. Additionally,
Peer Assessment Rating index). The majority of the studies pre-
they did not report the method of random sequence generation.
sented results for late orthodontic treatment in adolescence. Three
trials reported on final overjet, final ANB, final PAR score and
incidence of new incisal trauma for early treatment (Florida 1998; Allocation concealment
North Carolina 2004; UK (Mixed) 2009). One trial reported self- In eight studies (Banks 2004; Eissa 2017; Elkordy 2016; Martina
concept in early treatment (UK (Mixed) 2009). 2013; Thiruvenkatachari 2010; UK (11-14) 2003; UK (Mixed)
2009; Yaqoob 2012), allocation concealment was clearly described
and therefore these studies were judged at low risk of bias for this
Excluded studies domain. Eighteen studies did not report any information about
We excluded 104 studies. The main reasons for exclusion were as allocation concealment and were assessed as being at unclear risk
follows. See Characteristics of excluded studies table for further of bias for this domain (Aras 2017a; Aras 2017b; Alali 2014;
details. Baysal 2014; Bilgiç 2011; Burhan 2015; Cevidanes 2003; Cirgi
• 85 were not RCTs; 2016; Cura 1997; Florida 1998; Ghafari 1998; Jamilian 2011; Jin
• 4 had only abstracts and did not have sufficient information 2015; Lee 2007; London 1998; Mao 1997; North Carolina 2004;
to determine whether they met the inclusion criteria of the Showkatbakhsh 2011). One study reported that randomisation
review; was matched in triads according to age and sex and randomly
• 4 did not involve treatment of people with a Class II assigned to the three intervention groups (New Zealand 2000).
Division 1 malocclusion (or they were only a small proportion of It is possible that allocation could be predictable within the triad
participants); time. As a result, we felt that this study was at high risk of bias for
• 4 included Class II division 2 participants; this domain (New Zealand 2000).
• 5 included adults;
• 1 had no information on overjet and ANB;
Blinding
• 1 was imaging study of TMJ.
Blind assessment of all outcomes was reported in 13 studies
and these were assessed as at low risk of bias (Aras 2017a;
Risk of bias in included studies
Aras 2017b; Alali 2014; Banks 2004; Burhan 2015; Cevidanes
2003; Elkordy 2016; Florida 1998; Jamilian 2011; Martina 2013;
UK (11-14) 2003; UK (Mixed) 2009; Yaqoob 2012). Blind out-
Allocation come assessment was not reported in 10 studies and they were

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 12
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
judged at unclear risk of bias (Bilgi 2011; Cura 1997; Eissa 2017; 1998; London 1998; Martina 2013; New Zealand 2000; UK (11-
Ghafari 1998; Jin 2015; Lee 2007; London 1998; Mao 1997; 14) 2003). Seven of these studies had more than 20% attrition
New Zealand 2000; Showkatbakhsh 2011). An additional study and a significant difference in the rate and reason for participants
reported clinical measures only and blinding was not possible. being excluded from the analysis in each arm of the study (Banks
This was judged to be at unclear risk of bias (Thiruvenkatachari 2004; Cura 1997; Florida 1998; Ghafari 1998; London 1998;
2010). Three studies stated that the assessors were not blinded Martina 2013; New Zealand 2000). UK (11-14) 2003 had a lower
and were judged at high risk of bias (Baysal 2014; Cirgi 2016; overall attrition rate of 15% but the dropout rate was significantly
North Carolina 2004). different between groups.

Selective reporting
Incomplete outcome data
Twenty-four studies reported all of the outcomes specified in the
Trials of orthodontic treatment for Class II division 1 malocclusion methodology and were judged at low risk of reporting bias (Alali
typically last for at least five or more years and consequently there is 2014; Aras 2017a; Aras 2017b; Banks 2004; Baysal 2014; Bilgiç
a high rate of attrition, some of which is related to the orthodontic 2011; Burhan 2015; Cirgi 2016; Cura 1997; Eissa 2017; Elkordy
treatment offered, and some due to factors such as families moving 2016; Florida 1998; Ghafari 1998; Jamilian 2011; Jin 2015; Lee
to a different area. Attrition rates in the studies included in this 2007; London 1998; Martina 2013; New Zealand 2000; North
review ranged from 6% to 28% of participants initially randomised Carolina 2004; Thiruvenkatachari 2010; UK (11-14) 2003; UK
to treatments. In assessing risk of attrition bias, we looked at the (Mixed) 2009; Yaqoob 2012). One study reported only on a few
overall rate of attrition in the study, the relative loss for each arm cephalometric measurements and no clinical measurements so was
of each study and the reasons given to explain these. judged to be at unclear risk of bias (Showkatbakhsh 2011). One
We assessed 11 studies as being at low risk of attrition bias (Aras study used a complicated reporting method from which data could
2017a; Aras 2017b; Baysal 2014; Bilgiç 2011; Burhan 2015; not be extracted for meta-analysis and this study was judged at
Jamilian 2011; Jin 2015; Lee 2007; Showkatbakhsh 2011; UK unclear risk of reporting bias (Cevidanes 2003). The study by Mao
(Mixed) 2009; Yaqoob 2012). UK (Mixed) 2009 had high overall 1997 had reported data, but these were not clear and data could
attrition (19%) but the reasons given and the numbers were similar not be extracted for meta-analysis, so this study was also assessed
in each treatment arm and we considered that attrition bias was at unclear risk of reporting bias.
unlikely. Yaqoob 2012 had low overall attrition (6%) and reasons
and numbers were similar in each treatment arm.
A further eight studies were assessed as being at unclear risk Other potential sources of bias
of attrition bias (Alali 2014; Cirgi 2016; Cevidanes 2003; There was no other potential source of bias identified in 18
Eissa 2017; Elkordy 2016; Mao 1997; North Carolina 2004; studies and these were judged to be at low risk of bias (Aras
Thiruvenkatachari 2010). In two of these studies (Cevidanes 2003; 2017a; Alali 2014; Banks 2004; Baysal 2014; Bilgiç 2011; Burhan
North Carolina 2004), the overall rate of attrition was 10% to 2015; Eissa 2017; Florida 1998; Ghafari 1998; Jamilian 2011; Jin
19%, but there was incomplete information on the rates and rea- 2015; Martina 2013; New Zealand 2000; North Carolina 2004;
sons for participants being excluded from the analysis in each treat- Showkatbakhsh 2011; UK (11-14) 2003; UK (Mixed) 2009;
ment group within the study. In Alali 2014 the overall rate of at- Yaqoob 2012).
trition was 13% but there were more dropouts in the treatment Five studies were judged as being at unclear risk of other bias
(four participants, 16%) than in the control group (one partici- (Cevidanes 2003; Cirgi 2016; Elkordy 2016; Lee 2007; London
pant, 5%). Mao 1997 provided no information about the num- 1998). One study did not report baseline characteristics of the
ber of participants included in the outcome evaluation. The study groups (Cevidanes 2003). One study did not present the age of
by Thiruvenkatachari 2010 was stopped early and had more than participants at baseline (Cirgi 2016). The sample of one study
twice as many participants lost from the Twin Block treatment had only females (Elkordy 2016). One study had differences in
group compared to the Dynamax group. One study reported 46% age at baseline between randomised groups. Although this was
attrition rate for one of the outcomes measured (Cirgi 2016). not statistically significant (which may be due to small numbers
Cirgi 2016 also presented an imbalance between the treated in each group), this study was assessed as at unclear risk of other
groups with 43 participants analysed in one group and 62 in the bias (London 1998). Two studies found a higher incidence of
other group. One study reported uneven dropout rates between appliance breakages in the Dynamax group than in the Twin Block
groups and was therefore judged as unclear risk (Eissa 2017). In group (Lee 2007; Thiruvenkatachari 2010). Cirgi 2016 stopped
Elkordy 2016 there was no loss in the treated groups, but there recruitment midway and therefore had uneven numbers between
was a loss of 20% in the control group. groups.
We assessed the remaining eight studies as being at high risk of Four studies were assessed at high risk of other bias (Aras 2017b;
attrition bias (Banks 2004; Cura 1997; Florida 1998; Ghafari Cura 1997; Mao 1997; Thiruvenkatachari 2010). Cura 1997 and

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 13
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Aras 2017b had gender imbalance at baseline between groups, In summary, 15 studies were considered to be at high risk of bias
which may have led to a bias due to the different responses of boys in at least one domain and were therefore assessed to be at high risk
and girls to orthodontic treatment. Mao 1997 did not report data of bias overall (Aras 2017b; Banks 2004; Baysal 2014; Bilgi 2011;
clearly and also had gender imbalance between groups at baseline Cirgi 2016; Cura 1997; Florida 1998; Ghafari 1998; London
(Bionator group 18 males, six females and untreated group nine 1998; Mao 1997; Martina 2013; New Zealand 2000; North
males and 17 females). One study stopped prematurely due to Carolina 2004; Thiruvenkatachari 2010; UK (11-14) 2003); two
excessive adverse events and a statistically significant difference studies were considered to be at low overall risk of bias (UK
between groups at the first interim analysis and so was assessed to (Mixed) 2009; Yaqoob 2012); and 10 studies at unclear overall
be at high risk of bias (Thiruvenkatachari 2010). risk of bias (Aras 2017a; Alali 2014; Burhan 2015; Cevidanes
2003; Eissa 2017; Elkordy 2016; Jamilian 2011; Jin 2015; Lee
2007; Showkatbakhsh 2011) (Figure 2).
Overall risk of bias

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 14
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 2. Risk of bias summary: review authors’ judgements about each risk of bias item for each included
study.

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 15
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 did not carry out any dental measurements and therefore had no
data to contribute to the meta-analysis.
Effects of interventions Ghafari 1998 did not publish data at the end of the study. Partial
See: Summary of findings for the main comparison Early presentation of data in several interim publications could not be
treatment (two-phase: phase one in childhood and phase two in included in the analysis.
adolescence) versus late treatment (one-phase in adolescence) with Lee 2007 reported medians and interquartile range and these non-
functional appliance; Summary of findings 2 Early treatment parametric data could not be used in the meta-analysis. However,
(two-phase: phase 1 in childhood and phase 2 in adolescence) this study reported that there was no difference in overjet change
with headgear appliance versus late treatment (one-phase in between Twin Block and Dynamax appliances.
adolescence) with headgear; Summary of findings 3 Late Thiruvenkatachari 2010 stopped this trial early due to harms. The
treatment (one-phase in adolescence) with functional appliance incidence of adverse events with the Dynamax appliance (82%)
versus no treatment for prominent upper front teeth (Class II was significantly greater than the Twin Block appliance (12%) (P
malocclusion); Summary of findings 4 Late treatment (one-phase value < 0.001) and the Twin Block appliance was more effective
in adolescence): comparison among different types of appliances for overjet reduction. However, insufficient data were available to
used for treatment of prominent upper front teeth (Class II be used in the meta-analysis.
malocclusion); Summary of findings 5 Late treatment (one-phase
in adolescence): comparison among different types of appliances
used for treatment of prominent upper front teeth (Class II Early orthodontic treatment (two-phase) for Class II
malocclusion) division 1 malocclusion
We divided the trials into two main groups.
• Early orthodontic treatment for Class II Division 1
malocclusion. Early treatment (two-phase) versus late treatment in
adolescence (one-phase)
i) Comparison 1: early treatment (two-phase: phase one
in childhood (7 to 11 years) and phase two in adolescence (12 to
16 years)) versus late treatment (one-phase in adolescence). Outcomes at the end of phase one
a) Outcomes at the end of phase one (Comparisons
1.1 to 1.4).
b) Outcomes at the end of phase two (Comparisons
1.5 to 1.8). Treatment with functional appliance
ii) Comparison 2: early orthodontic treatment (two- Three trials (two at high risk of bias, one at low risk of bias) com-
phase): different types of appliances. pared early treatment (two-phase) using a functional appliance,
a) Outcomes at the end of phase one (Comparisons with late treatment in adolescence (one-phase) (Florida 1998;
2.1 and 2.2). North Carolina 2004; UK (Mixed) 2009). Data were available
b) Outcomes at the end of phase two (Comparisons comparing outcomes at the end of phase one for the early treat-
2.3 and 2.4). ment group with observation only in the late treatment group.
The meta-analysis showed that there was a statistically significant
• Late orthodontic treatment in adolescence (one-phase) for difference in the overjet in favour of the treated group at the end
Class II Division 1 malocclusion. of phase one (mean difference (MD) −4.17 mm, 95% confidence
interval (CI) −4.61 to −3.73, Chi² = 117.02, 2 degrees of freedom
i) Comparison 3: late treatment in adolescence with (df ), P value < 0.00001, I² = 98%; three studies, 432 participants)
functional appliances versus no treatment (Comparison 3.1). (Analysis 1.1).
ii) Comparison 4: different types of appliances used for When we evaluated the effect of treatment on final ANB, we found
late treatment in adolescence (Comparisons 4.1 to 4.10). that there was a statistically significant mean difference between
the treatment and control groups in favour of functional appliance
Four studies were not included in meta-analysis (Cevidanes 2003; treatment (MD −0.89°; 95% CI −1.38° to −0.40°, Chi² = 9.17,
Ghafari 1998; Lee 2007; Thiruvenkatachari 2010). 2 df, P value = 0.0004, I² = 78%; three studies, 419 participants).
Cevidanes 2003 looked at the effects of functional appliances There was also a statistically significant effect on the PAR score
(Frankel appliance) on the temporomandibular joint. This study in favour of early treatment (MD −10.52, 95% CI −12.32 to

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 16
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
−8.71, Chi² = 52.23, 2 df, P value < 0.00001, I² = 98%; two (Analysis 1.6) compared with late orthodontic treatment during
studies, 249 participants) (Analysis 1.1). adolescence (one-phase). The reduction in the incidence of new
Early treatment did not show any significant difference in self- incisal trauma by the end of phase two was clinically significant
concept score (MD −3.63, 95% CI −7.66 to 0.40, P value = 0.08; with 30% (51/171) of participants reporting new trauma inci-
one study, 135 participants) (Analysis 1.1); and incidence of new dence in the late treatment group compared to only 19% (31/161)
incisal trauma at the end of phase 1 (odds ratio (OR) 0.72, 95% CI in the early treatment group.
0.35 to 1.49, P value = 0.38; two trials, 281 participants) (Analysis
1.2) when compared with untreated control group participants.

Treatment with headgear when younger

Treatment with headgear Two trials, both at high risk of bias, compared early treatment
Two trials, both at high risk of bias, compared early treatment (two-phase), using headgear, with late treatment in adolescence
(two-phase), using headgear, with late treatment in adolescence (one-phase) (Florida 1998; North Carolina 2004). There were no
(one-phase) (Florida 1998; North Carolina 2004). The compari- statistically significant effects of an early course of headgear treat-
son of the effect of treatment with headgear at the end of phase one ment in childhood followed by treatment in adolescence with re-
(early treatment group), compared with observation (late treat- spect to final overjet (MD −0.22 mm, 95% CI −0.56 mm to
ment group), revealed a statistically significant effect of headgear 0.12 mm, Chi² = 1.27, 1 df, P value = 0.20, I² = 21%; 238 partic-
treatment, in the reduction of the overjet (MD −1.07 mm, 95% ipants) (Analysis 1.7), final ANB (MD −0.27°, 95% CI −0.80°
CI −1.63 mm to −0.51 mm, Chi² = 0.05, 1 df, P value = 0.0002, to 0.26°, Chi² = 0.10, 1 df, P value = 0.32, I² = 0%; 231 partici-
I² = 0%; 278 participants) (Analysis 1.3). Similarly, headgear re- pants) (Analysis 1.7), or PAR score (MD −1.55, 95% CI −3.70
sulted in a statistically significant reduction of −0.72° (95% CI to 0.60, Chi² = 0.39, 1 df, P value = 0.16, I² = 0%; 177 partic-
−1.18° to −0.27°, Chi² = 0.34, 1 df, P value = 0.002, I² = 0%; ipants) (Analysis 1.7) compared with one phase of treatment in
277 participants) in final ANB (Analysis 1.3). However, there was adolescence. However, the incidence of new incisal trauma showed
no statistically significant difference in new incisal trauma (OR a statistically significant reduction in the earlier treatment (two-
0.76, 95% CI 0.37 to 1.54, Chi² = 0.66, 1 df, P value = 0.44, I² phase) group (OR 0.45, 95% CI 0.25 to 0.80, Chi² = 1.15, 1 df,
= 0%) between the two groups (Analysis 1.4). P value = 0.007, I² = 13%; 237 participants) (Analysis 1.8). The
group who had late treatment in adolescence (one-phase) suffered
twice the incidence of new incisal trauma (44/120) as compared
Outcomes at the end of phase two to the group who had early headgear treatment (two-phase) in
childhood (24/117).

Treatment with functional appliance

Three trials (two at high risk of bias, one at low risk of bias) com- Early orthodontic treatment in children (two-phase):
pared early treatment (two-phase) with a functional appliance ver- different types of appliances
sus late treatment in adolescence (Florida 1998; North Carolina
2004; UK (Mixed) 2009). When we evaluated the effects of a
course of treatment for children (one-phase) with a functional ap-
Outcomes at the end of phase one
pliance and at the end of all orthodontic treatment during adoles-
cence (one-phase), we found that there were no statistically signif- Two trials, at high risk of bias, compared the use of different types
icant differences in final overjet (MD 0.21 mm, 95% CI −0.10 of appliances (headgear and functional appliance) for early treat-
mm to 0.51 mm, Chi² = 5.23, 2 df, P value = 0.18, I² = 62%; ment (two-phase) (Florida 1998; North Carolina 2004). When
343 participants) (Analysis 1.5), final ANB (MD −0.02°; 95% CI we compared the effects of treatment with headgear or functional
−0.47° to 0.43°, Chi² = 2.62, 2 df , P value = 0.92, I² = 24%; 347 appliances in children, we found statistically significant differences
participants) (Analysis 1.5), PAR score (MD 0.62, 95% CI −0.66 with respect to final overjet (MD 0.75 mm, 95% CI 0.21 mm to
to 1.91, Chi² = 6.43, 2 df, P value = 0.34, I² = 69%; 360 par- 1.29 mm, Chi² = 12.54, 1 df, P value = 0.006, I² = 92%; 271 par-
ticipants) (Analysis 1.5), or self-concept score (MD −0.83, 95% ticipants) (Analysis 2.1) in favour of functional appliances, but no
CI −3.97 to 2.31, P value = 0.60; one study, 132 participants). difference in final ANB (MD −0.04°, 95% CI −0.49° to 0.41°,
However, the incidence of new incisal trauma showed a statisti- Chi² = 0.03, 1 df, P value = 0.85, I² = 0%; 271 participants)
cally significant difference, in favour of early functional appliance (Analysis 2.1), or new incisal trauma (OR 1.02, 95% CI 0.48 to
treatment in childhood (two-phase) (OR 0.56, 95% CI 0.33 to 2.17, Chi² = 0.22, 1 df, P value = 0.95, I² = 0%; 282 participants)
0.95, Chi² = 1.98, 2 df, P value = 0.03, I² = 0%; 332 participants) (Analysis 2.2).

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 17
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Outcomes at the end of phase two Burhan 2015; Jamilian 2011); and two at high risk of bias (London
An evaluation of the effect of treatment between headgear and 1998; UK (11-14) 2003). There was no statistically significant
functional appliance in children followed by treatment in adoles- effect of the type of appliance on final overjet (MD 0.08 mm,
cence revealed no significant difference in final overjet (MD −0.21 95% CI −0.60 to 0.76, P = 0.83; 259 participants) (Analysis 4.1).
mm, 95% CI −0.57 mm to 0.15 mm, Chi² = 0.01, 1 df, P value Six trials evaluated ANB (Baysal 2014; Burhan 2015; Jamilian
= 0.26, I² = 0%; 225 participants) (Analysis 2.3), final ANB (MD 2011; Jin 2015; London 1998; UK (11-14) 2003). Three of them
−0.17°, 95% CI −0.67° to 0.34°, Chi² = 1.58, 1 df, P value = were at high risk of bias (Baysal 2014; London 1998; UK (11-14)
0.52, I² = 37%; 222 participants) (Analysis 2.3), PAR score (MD 2003); and three at unclear risk of bias (Burhan 2015; Jamilian
−0.81, 95% CI −2.21 to 0.58, Chi² = 0.09, 1 df, P value = 0.25, 2011; Jin 2015). There was a statistically significant reduction in
I² = 0%; 224 participants) (Analysis 2.3), or the incidence of in- ANB with the Twin Block when compared to other functional
cisal trauma (OR 0.78, 95% CI 0.42 to 1.47, Chi² = 0.08, 1 df, appliances (MD −0.56°, 95% CI −0.96 to −0.16, P = 0.006;
P value = 0.45, I² = 0%; 226 participants) (Analysis 2.4) (Florida 320 participants) (Analysis 4.1).
1998; North Carolina 2004).

Twin Block functional appliance versus other modifications

Late orthodontic treatment in adolescence (one-
of Twin Block appliances
phase) for Class II Division 1 malocclusion
Two trials compared a Twin Block functional appliance versus
other modifications of Twin Block appliances; one trial was at
Late orthodontic treatment: functional appliance versus no high risk of bias and one at low risk of bias (Banks 2004; Yaqoob
treatment 2012). There were no statistically significant differences between
Seven trials compared the use of functional appliances against no the Twin Block designs with respect to final overjet (MD −0.23
treatment. We decided, after considering the clinical and statistical mm, 95% CI −0.67 mm to 0.22 mm, Chi² = 2.59, 1 df, P value
heterogeneity, to analyse the trials according to the type of func- = 0.11, I² = 61%; 196 participants) (Analysis 4.2).
tional appliance: fixed or removable. Three trials evaluated fixed Activator functional appliance versus prefabricated myobrace
functional appliances (Alali 2014; Eissa 2017; Elkordy 2016), all appliance (PFA)
of which were assessed as being at unclear risk of bias overall. The The results in this section are based on a single trial at high risk of
other four trials evaluated removable functional appliances and bias (Cirgi 2016). There was no statistically significant difference
we assessed these trials as being at high risk of bias overall (Cura between the two groups with respect to final overjet (MD 0.60
1997; Mao 1997; Martina 2013; New Zealand 2000). The overall mm, 95% CI −1.63 to 0.43, P value = 0.25; 97 participants)
quality of the evidence was low. (Analysis 4.3).
There was evidence of a reduction in overjet with both removable
functional appliances (MD −4.62, 95% CI -5.33 to -3.92, P <
0.00001; three trials, 122 participants) and fixed functional appli- Activator functional appliance versus fixed functional
ance (MD −5.46, 95% CI −6.63 to −4.28, P < 0.00001; two tri- (FORSUS FRD EZ) appliances
als, 61 participants) when compared with no treatment (Analysis
3.1). The results in this section are based on one trial (24 participants)
There was no evidence of a clear difference between use of the fixed at high risk of bias (Bilgiç 2011). Reduction in overjet favoured
appliance and no treatment for final ANB (MD −0.53, 95% CI the FORSUS appliance (MD 2.19 mm, 95% CI 0.58 mm to 3.80
−1.27 to −0.22, P = 0.17; three trials, 89 participants) (Analysis mm, P value = 0.008) (Analysis 4.4); but final ANB favoured the
3.2). However, the removable functional appliance reduced ANB Activator group (MD −1.74°, 95% CI −3.28° to −0.20°, P value
significantly compared to no treatment (MD −2.37°, 95% CI - = 0.03) (Analysis 4.4).
3.01 to -1.74, P < 0.00001; two trials, 99 participants) (Analysis Fixed functional (FORSUS FRD) versus fixed functional with
3.2). mini-implants (FMI)
Two trials, both at unclear risk of bias (Elkordy 2016; Eissa 2017),
evaluated this comparison and found no significant difference be-
Late orthodontic treatment: different types of appliances tween the two groups with respect to final overjet (MD -0.36,
95% CI -1.07 to 0.35, P value = 0.32; one trial, 29 participants)
and final ANB (MD 0.22, 95% CI -0.86 to 1.30, P value = 0.69;
Twin Block functional appliance versus other functional two trials, 60 participants) (Analysis 4.5).
appliances There was no difference between the groups in patient satisfaction
Four trials evaluated overjet (Burhan 2015; Jamilian 2011; London (OR 0.18, 95% CI 0.01 to 3.97, P value = 0.27; one trial, 32
1998; UK (11-14) 2003). Two of them were at unclear risk of bias ( participants) (Analysis 4.6).

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 18
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
R-appliance versus anterior inclined bite plate (AIBP) The results in this section are based on one trial at high risk of
bias (Aras 2017b). The results showed no statistically significant
A single trial at unclear risk of bias showed no statistically sig- difference for final overjet (MD 0.28, 95% CI -0.35 to 0.91, P =
nificant difference between the two groups with respect to final 0.39; 28 participants) or final ANB (MD -0.90, 95% CI -1.96 to
ANB (MD −0.30°, 95% CI −0.99° to 0.39°, P value = 0.40; 50 0.61, P = 0.10; 28 participants) (Analysis 4.9).
participants) (Showkatbakhsh 2011) (Analysis 4.7). FMA stepwise (SWG) versus FMA single step (SSG)
Removable functional versus fixed functional The results are based on a single trial at unclear risk of bias (
Three trials at high risk of bias compared orthodontic treatment Aras 2017a). There was no statistically significant difference for
for adolescents with removable functional appliances to fixed func- final overjet (MD 0.23, 95% CI -0.26 to 0.72, P = 0.36; 34
tional appliances (Baysal 2014; Bilgiç 2011; UK (11-14) 2003). participants), but the results favoured stepwise advancement for
There was a statistically significant difference between the groups final ANB value (MD -0.69, 95% CI -1.19 to -0.19, P = 0.007;
in overjet (MD 0.74, 95% CI 0.15 to 1.33, P = 0.01; two trials, 34 participants) (Analysis 4.10).
154 participants) in favour of fixed functional appliances (Analysis Harvold Activator versus Frankel function regulator
4.8). However, a statistically significant difference in final ANB of The results are based on a single trial at high risk of bias (New
−1.04° (95% CI −1.60 to −0.49, P = 0.0002; three trials, 185 Zealand 2000). There was a statistically significant difference in
participants) was found in favour of removable functional appli- the overjet change favouring Harvold Activator when compared
ances (Analysis 4.8). with Frankel function regulator (MD -2.23, 95% CI -5.37 to 0.49,
Fixed functional (FORSUS FRD) versus intermaxillary elastics P = 0.02; 25 participants) (Analysis 4.11).

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 19
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) A D D I T I O N A L S U M M A R Y O F F I N D I N G S [Explanation]

Early treatment (two- phase: phase 1 in childhood and phase 2 in adolescence) with headgear appliance versus late treatment (one- phase in adolescence) with headgear

Patient or population: children and/ or adolescents (age ≤ 16 years) receiving orthodontic treatm ent to correct prom inent upper f ront teeth
Intervention: early treatm ent with headgear
Comparison: late treatm ent with headgear

Outcomes Illustrative comparative risks* (95% CI) Relative effect No of participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)

Assumed risk Corresponding risk

Late treatment with Early treatment with

headgear headgear

Overjet (m m ) M ean f inal overjet M ean f inal overjet in 238 (2) ⊕⊕ Headgear reduced
(sm aller value better) ranged across control the 2-phase treatm ent low2 overjet com pared to no
Follow-up at end of or- groups f rom 2.4 m m to group was 0.22 m m treatm ent at the end of
thodontic treatm ent 3.48 m m less (0.56 m m less to the f irst phase of early
0.12 m m m ore) treatm ent (M D −1.07,
−1.63 to −0.51; 278
participants)

Incidence of incisal 367 per 1000 1 207 per 1000 (126 to OR 0.45 (0.25 to 0.80) 237 (2) ⊕⊕
traum a 317) low2
Follow-up at end of or-
thodontic treatm ent

ANB (°) M ean f inal ANB ranged M ean f inal ANB 0.27° 231 (2) ⊕⊕ Headgear im -
Follow-up at end of or- across control groups less (0.80° less to 0.26° low2 proved ANB com pared
thodontic treatm ent f rom 3.3° to 4.0° m ore) to no treatm ent at the
end of the f irst phase
of early treatm ent (M D
−0.72, −1.18 to −0.27;
277 participants)
20
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)

* The basis f or the assumed risk (e.g. the m edian control group risk across studies) is provided in f ootnotes. The corresponding risk (and its 95% CI) is based on the assum ed
risk in the com parison group and the relative effect of the intervention (and its 95% CI)
CI: conf idence interval; M D: m ean dif f erence; OR: odds ratio

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our conf idence in the estim ate of ef f ect.
M oderate quality: Further research is likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and m ay change the estim ate.
Low quality: Further research is very likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and is likely to change the estim ate.
Very low quality: We are very uncertain about the estim ate.
1 Based on average in control groups
2 Downgraded twice as both studies at high risk of bias
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21
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)

Late treatment (one- phase in adolescence) with functional appliance versus no treatment for prominent upper front teeth (Class II malocclusion)

Patient or population: adolescents (age between 12 and 16 years) receiving orthodontic treatm ent to correct prom inent upper f ront teeth
Intervention: late treatm ent in adolescence with dif f erent types of f unctional appliances
Comparison: no treatm ent

Outcomes Illustrative comparative risks∗ (95% CI) Relative effect Number of participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)

Assumed risk Corresponding risk

No treatment Late treatment with

functional appliances

Fixed functional appliances

Overjet (m m ) M ean f inal overjet M ean f inal overjet was 61 ⊕⊕

(sm aller value better) ranged f rom 7.47 to 10. 5.46 m m lower (2) low 1
Follow-up at end of or- 56 m m (6.63 lower to 4.28
thodontic treatm ent lower)

Incidence of incisal Not m easured

traum a

ANB (°) M ean f inal ANB ranged M ean f inal ANB was 0. 89 ⊕⊕
Follow-up at end of or- f rom 6.30° to 7.92° 53° lower (3) low 2
thodontic treatm ent (1.27 lower to 0.22
lower)

Removable functional appliances

Overjet (m m ) M ean f inal overjet M ean f inal overjet was 122 ⊕⊕

(sm aller value better) ranged f rom 7.8 to 9.9 4.62 m m lower (5.33 (3) low 3
Follow-up at end of or- m m lower to 3.92 lower)
thodontic treatm ent
22
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)

Incidence of incisal Not m easured

traum a

ANB (°) M ean f inal ANB ranged M ean f inal ANB was 2. 99 ⊕⊕
Follow-up at end of or- f rom 6.5° to 6.53° 37° lower (2) low 3
thodontic treatm ent (3.01 lower to 1.74
lower)
1 Downgraded one level as both studies were at unclear risk of bias and one level because of very high heterogeneity (I² =
95%)
2 Downgraded one level as the three studies were at unclear risk of bias and one level f or m oderate heterogeneity (I² = 51%)
3 Downgraded two levels as both studies were at high risk of bias

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23
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)

Late treatment (one- phase in adolescence): comparison among different types of appliances used for treatment of prominent upper front teeth (Class II malocclusion)

Patient or population: adolescents (age between 12 and 16 years) receiving orthodontic treatm ent to correct prom inent upper f ront teeth
Intervention: late treatm ent in adolescence with dif f erent types of appliances
Comparison: Twin Block

Outcomes Illustrative comparative risks∗ (95% CI) Relative effect (95%CI) of participants Quality of the evidence Comments
(studies) (GRADE)

Assumed risk Corresponding risk

Different types of ap- Twin Block

pliances

Overjet (m m ) M ean f inal overjet M ean f inal overjet was 259 ⊕⊕

(sm aller value better) ranged f rom 2.68 m m 0.08 m m higher (4) low 12
Follow-up at end of or- to 4.40 m m (0.6 lower to 0.76
thodontic treatm ent higher)

Incidence of Incisal Not m easured

traum a

ANB (°) M ean f inal ANB ranged M ean f inal ANB was 320 ⊕⊕
Follow-up at end of or- f rom 3.63° to 5.00° −0.56° lower (6) low 34
thodontic treatm ent (0.96 lower to 0.16
lower)

* The basis f or the assumed risk (e.g. the m edian control group risk across studies) is provided in f ootnotes. The corresponding risk (and its 95% CI) is based on the assum ed
risk in the com parison group and the relative effect of the intervention (and its 95% CI)
CI: Conf idence interval; M D: M ean

GRADE Working Group grades of evidence

High quality: We are very conf ident that the true ef f ect lies close to that of the estim ate of the ef f ect
M oderate quality: We are m oderately conf ident in the ef f ect estim ate: The true ef f ect is likely to be close to the estim ate of the ef f ect, but there is a possibility that it is
substantially dif f erent
Low quality: Our conf idence in the ef f ect estim ate is lim ited: The true ef f ect m ay be substantially dif f erent f rom the estim ate of the ef f ect
Very low quality: We have very little conf idence in the ef f ect estim ate: The true ef f ect is likely to be substantially dif f erent f rom the estim ate of ef f ect
24
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)
1
Downgraded as 2 of 4 studies were at high risk of bias
2 Dowgraded due to heterogeneity (heterogeneity: Tau² = 0.25; Chi² = 6.61, df = 3 (P = 0.09); I² = 55%)
3 Downgraded as 3 of 6 studies were at high risk of bias
4 Downgraded as the interventions in the com parison groups were not sim ilar

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25
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)

Late treatment in adolescence (one- phase): comparison among different types of appliances used for treatment of prominent upper front teeth (Class II malocclusion)

Patient or population: adolescents (age between 12 and 16 years) receiving orthodontic treatm ent to correct prom inent upper f ront teeth
Intervention: Rem ovable f untional appliance
Comparison: Fixed f untional appliance

Outcomes Illustrative comparative risks∗ (95% CI) Relative effect (95%CI) Number of participants Quality of the evidence Comments
(studies) (GRADE)

Assumed risk Corresponding risk

Fixed functional appli- Removable functional

ance appliance

Overjet (m m ) M ean f inal overjet M ean f inal overjet was 154 ⊕⊕

(sm aller value better) ranged f rom 0.95 m m 0.74 m m higher (0.15 (2) low 12
Follow-up at end of or- to 3.53 m m lower to 1.33 higher)
thodontic treatm ent

Incidence of Incisal Not m easured

traum a

ANB (°) M ean f inal ANB ranged M ean f inal ANB was 1. 185 ⊕⊕
Follow-up at end of or- f rom 4.40° to 5.88° 04° lower (3) low 34
thodontic treatm ent (1.6 lower to 0.49
lower)

* The basis f or the assumed risk (e.g. the m edian control group risk across studies) is provided in f ootnotes. The corresponding risk (and its 95% CI) is based on the assum ed
risk in the com parison group and the relative effect of the intervention (and its 95% CI)
CI: Conf idence interval; M D: M ean dif f erence

GRADE Working Group grades of evidence

High quality: We are very conf ident that the true ef f ect lies close to that of the estim ate of the ef f ect
M oderate quality: We are m oderately conf ident in the ef f ect estim ate: The true ef f ect is likely to be close to the estim ate of the ef f ect, but there is a possibility that it is
substantially dif f erent
Low quality: Our conf idence in the ef f ect estim ate is lim ited: The true ef f ect m ay be substantially dif f erent f rom the estim ate of the ef f ect
Very low quality: We have very little conf idence in the ef f ect estim ate: The true ef f ect is likely to be substantially dif f erent f rom the estim ate of ef f ect
26
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review)
1
Downgraded due to inconsistency (interventions were not sim ilar between studies)
2 Downgraded twice as both studies were at high risk of bias
3 Downgraded due to inconsistency (interventions were not sim ilar between studies)
4 Downgraded twice as 3 trials were at high risk of bias
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27
DISCUSSION Overall completeness and applicability of
evidence
One important finding from this review was that while we iden-
tified 27 RCTs, they had been published in 63 different papers.
Summary of main results Furthermore, several of the investigators had not only reported
outcomes at the end of early treatment, but they had produced
several papers that were confined to analysis of subsets of partici-
Early treatment (two-phase) versus late treatment in pants, to form interim reports or ’updates’. While they may have
adolescence (one-phase) had good reasons to follow this publication strategy, in terms of
having to compete for the renewal of grant funding, this did re-
We have found evidence that orthodontic treatment provided to sult in difficulty interpreting the results of these studies. We ap-
7 to 11 year olds with prominent upper front teeth results in a proached this problem by identifying the most relevant outcomes
statistically significant reduction in incisor prominence. This effect and data points and then produced composite data extraction for
occurs if the child received treatment with a functional appliance these studies. We would like to suggest that studies are not re-
or headgear. This treatment also resulted in some changes in the ported until they are completed. The registration of trials will go
relationship of the upper and lower jaws. However, while these some way to addressing some of these issues, where each trial has
changes or differences at the end of phase one were statistically a unique identity number that will appear on all publications.
significant, the quality of evidence for this comparison is low. In this review we have analysed data at the end of phase one and
When we considered the final outcome of treatment at the end phase two in studies that evaluated the effect of early treatment.
of a second phase of treatment in adolescence, we found that the This is because these trials were carried out to evaluate the effec-
treatment was effective, in that incisor prominence had been re- tiveness of early treatment provided when the children were 7 to
duced. There were no differences in treatment outcome between 11 years old. These studies were then extended to the completion
the group who had received treatment at a younger age or treat- of all orthodontic treatment and included in this review. It could
ment in adolescence for any variable other than the incidence of be suggested that we should only report the final findings of these
new incisal trauma. The results showed a significant reduction in trials. However, we feel that the ’early’ treatment studies should
incisor trauma in the early treatment (two-phase) group as com- be included to illustrate that there were some short-term benefits:
pared to the late treatment (one-phase) group. The quality of the for example, reduction in overjet and possible increase in self-es-
evidence for this comparison is low to moderate. teem. Nevertheless, these findings do not detract from the overall
conclusions that early treatment is of limited benefit.
Finally, there was great variation in the outcome measures that were
Treatment provided in adolescence (one-phase) adopted by the investigators. This was particularly marked with
We found seven studies that measured the effect of treatment with the use of cephalometric analyses and is not surprising when we
a functional appliance versus an untreated control. Heterogeneity consider that there are many different types of analysis. We would
was high, and we analysed fixed and removable appliances sepa- suggest that uniformly applied cephalometric analyses are used
rately. We found significant reductions in final overjet with fixed when future studies are planned, so that adequate comparisons
and removable functional appliances (Analysis 3.1). There was ev- between trials can be achieved.
idence for a reduction in final ANB with removable functional ap-
pliances. The quality of the evidence was low for both outcomes.
We also found that several studies compared the effect of the Twin
Block functional appliance against other functional appliances, for Quality of the evidence
example the Bionator and Herbst appliances. We found that while We found 27 RCTs evaluating orthodontic treatment of peo-
there was a statistically significant difference in skeletal changes ple with prominent upper front teeth (Class II malocclusion).
(ANB) in favour of Twin Block. The quality of the evidence was The overall quality of evidence in this review was low (Summary
low. of findings for the main comparison; Summary of findings 2;
There were three trials that compared orthodontic treatment for Summary of findings 3; Summary of findings 4; Summary of
adolescents with removable functional appliances to fixed func- findings 5), with only two trials assessed as being at low risk of bias
tional appliances. Although a statistically significant reduction in (UK (Mixed) 2009; Yaqoob 2012). There were three two-phase
ANB was found in favour of removable functional appliances, and studies that contributed data to this review (Florida 1998; North
a statistically significant reduction in overjet was found in favour Carolina 2004; UK (Mixed) 2009). It is important to mention
of fixed functional appliances, the changes were so small that they that carrying out a trial of a two-phase study (treatment for young
may not be of clinical importance. Additionally, the quality of the children followed by treatment in adolescence) is much more dif-
evidence was low for both. ficult and potentially more prone to bias than a one-phase study.

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 28
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
However, in this review, the two-phase studies were of better qual- fixed functional appliances versus untreated Class II; and Pacha
ity than most of the one-phase studies. 2016 compared fixed versus removable functional appliances. This
It is important to point out that one study did not report a com- makes it impossible to compare the results with the present review.
plete data set. Although six different articles were published, none
of them included a complete data set and did not give reasons for
not doing so (Ghafari 1998).
It is interesting to note that one study was prematurely stopped AUTHORS’ CONCLUSIONS
due to harms (Thiruvenkatachari 2010). The study compared the
Twin Block and the Dynamax appliances and showed a statistically Implications for practice
significant overjet reduction in the Twin Block group at the end
of the first interim analysis. The study also reported significantly Orthodontic treatment for children, followed by a later phase of
greater incidence of harms with the Dynamax appliance. treatment when in adolescence, may significantly reduce the inci-
dence of incisal trauma as compared to treatment that is provided
in one phase in adolescence. There seem to be no other advantages
for providing a two-phase treatment in children compared to one-
Potential biases in the review process phase in adolescence.
A potential bias could be reporting bias. We avoided this by car-
Orthodontic treatment with functional appliances in adolescents
rying out a broad search with no restrictions on language or pub-
with prominent upper front teeth appears to significantly reduce
lication status.
the protrusion of the upper teeth when compared to adolescents
Another potential bias in the review could be our categorisation
who are not treated.
based on terminology of ’early’ and ’late’ treatment. In the pro-
tocol, we defined early treatment as treatment initiated between
Implications for research
7 and 11 years of age and late treatment as treatment initiated
between 12 and 16 years of age. Some studies were difficult to Consideration needs to be given to forming a consensus on the
categorise as they had recruited participants between 9 and 12 type of outcome measures that are used in orthodontic trials; this
years of age (see Characteristics of included studies section). As the is particularly relevant for cephalometric measurement and anal-
’early’ and ’late’ terminologies are accepted globally, we considered ysis. In addition, studies should be carried out at the same time
two-phase studies as early treatment and one-phase studies as late points and reported according to the Consolidated Standards of
treatment. Reporting Trials (CONSORT) guidelines. Moreover, intention-
to-treat analysis should be carried out properly, since attrition bias
was the most common risk of bias in this review: it was considered
’high risk’ in 8 of the 27 studies.
Agreements and disagreements with other
studies or reviews
There are several systematic reviews that have been performed
on the effects of functional appliances for patients with increased
ACKNOWLEDGEMENTS
overjet (Antonarakis 2007; Barnett 2008; Cozza 2006; Flores-Mir
2007; Perillo 2012; Ehsani 2015; Koretsi 2015; Zymperdikas Current update (2017): our thanks to Osama Alali (University of
2016; Yang 2016; Pacha 2016). Antonarakis 2007 reported that Damascus), Ahmad Burhan (Al-Baath University), Sherif Elko-
functional appliances show a statistically significant reduction in
rdy (Cairo University) and Emina irgi (University of Gothen-
overjet and ANB value when compared with untreated controls.
burg) for providing additional data for this review. We would like
However, the authors have included prospective and retrospective
to thank Janet Lear (Cochrane Oral Health) for her help to find
studies and did not separate early and late treatment. This makes
some papers and Professors Chengge Hua, Chunjie Li and Huimin
it difficult to compare with the present review. Similarly, Barnett
Hu for their translation support from Chinese. We thank Laura
2008, Cozza 2006, Flores-Mir 2007, Perillo 2012, Ehsani 2015,
MacDonald, Anne Littlewood, Dr Fang Hua, Professor Anne-
Koretsi 2015, Zymperdikas 2016, Yang 2016, and Pacha 2016 in-
Marie Glenny and Professor Helen Worthington of Cochrane Oral
cluded non-randomised studies. Cozza 2006 evaluated the effects
Health, copy editor Jason Elliot-Smith, and external referees Pro-
of functional appliances on mandibular length and did not report
fessor Ross Hobson and Dr Philipe Amat.
on other dental measurements. Barnett 2008, Flores-Mir 2007
and Yang 2016 were confined to the Herbst appliance, whereas Previous versions: we are very grateful to Helen Worthington for
Perillo 2012 evaluated the Frankel appliance and Ehsani 2015 her work on previous versions of this review. Thanks to Anne
studied Twin-Block. Koretsi 2015 compared removable functional Littlewood (Cochrane Oral Health) for her help in conducting
appliances versus untreated Class II; Zymperdikas 2016 compared the searches, and to Luisa Fernandez Mauleffinch (Cochrane Oral

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 29
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Health) for editorial management of the review. Thanks to Bill
Shaw for his initial advice; Bill Proffit, Kitty Tulloch (University
of North Carolina), Tim Wheeler, Sue McGorry (University of
Florida), David Morris, Danny Op Heij and Urban Hagg for pro-
viding additional data for this review; John Scholey for under-
taking some of the handsearching and Sue Pender for retrieving,
copying and collating the full papers. We would also like to thank
Susan Furness (Cochrane Oral Health) and all those who have
provided comments and editorial input.

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Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 32
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
References to studies excluded from this review Booij 2013 {published data only}
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Davoody 2011 {published data only} Fernandes 2010 {published data only}
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Indicates the major publication for the study

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 39
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Alali 2014

Methods Location: Syria

Number of centres: 1. University of Damascus
Recruitment period: not specified
Funding source: not specified
Trial design: parallel group RCT

Participants Inclusion criteria: Class II/1 malocclusion with (overjet > 4 mm); mild to moderate
skeletal Class II (ANB > 4° and APg/NL < 80°) with retrognathic mandible (SNB < 76°)
; the Fishman method was used to assess the hand-wrist radiographs, and only patients
in the pubertal growth spurt peak, which occurs between stages 4 and 7 at the beginning
of the treatment/observation period, were invited
Exclusion criteria: none stated
Age at baseline: mean age 13.2 years (SD 0.9) for Group 1 and 12.5 (SD 2.1) years for
group 2
Number randomised: 43
Number evaluated: 38

Interventions Gp 1 (n = 21): fixed lingual mandibular growth modificator

Gp 2 (n = 17): control - no or delayed treatment

Outcomes Multiple cephalometric variables

Notes Duration of randomised treatment (months): Gp 1 and Gp 2 = 8 months

Sample size calculation: “Clinical and statistical significance in mandibular length change
was defined, in the literature, as at least a +2-mm difference between Class II treated
and untreated groups. Based on that difference and standard deviation from previous
investigations, a power analysis determined that, for a two-sided 5% significance level and
a power of 80%, a sample size of 16 per group would be required. Accordingly, assignment
continued until 25 patients had enrolled in the treatment group to compensate for any
unexpected dropouts. In the control group, the enrollment continued until the minimum
number of patients required to satisfy the statistical power was reached.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk “All subjects were randomized by the au-
bias) thor at the beginning of the study to either
the treatment or control group.”

Allocation concealment (selection bias) Unclear risk Not described

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 40
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Alali 2014 (Continued)

Blinding of outcome assessment (detection Low risk “Cephalograms were digitized on screen
bias) and analyzed in a blind manner by the same
All outcomes orthodontist using cephalometric software.
”

Incomplete outcome data (attrition bias) Unclear risk FLMGM group recruited 25, analysed
All outcomes 21 (loss 16%)
Control group recruited 18, analysed 17
(loss 5%)
Reasons for discontinuation:
FLMGM group unable to return for final
records because of change of residence (n =
4)
Control group unable to return for final
records because of change of residence (n =
1)

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other sources of bias identified

Aras 2017a

Methods Location: Turkey

Number of centres: 1
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: angle Class II Division 1 malocclusion in the permanent dentition
with an overjet greater than 6 mm and full-cusp Cl II molar relationship; ANB greater
than 48 with retrognathic mandible; mild or no crowding; growth period just before or
at the peak of pubertal growth (evaluated by hand-wrist radiographs); and SN-GoGn
not exceeding 388
Exclusion criteria: none stated
Age at baseline: Gp 1: 13.48 years (SD 0.88); Gp 2: 13.15 years (SD 0.77); Gp 3: 13.
76 years (SD 0.62)
Number randomised: 36 (18 in each group)
Number evaluated: 34 (2 dropouts)

Interventions Gp 1 (n = 17): FMA using stepwise mandibular advancement (SWG)

Gp 2 (n = 17): FMA using single-step advancement (SSG)

Outcomes Cephalometric radiographs to assess soft tissues and dentoskeletal effects

Notes Sample size: “the power analysis with 0.05 level and 80% power (based on a 0.62-mm
standard deviation and a 0.6-mm detectable difference), the needed minimum sample
size was 17 for each group”

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Aras 2017a (Continued)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Matched randomization was used for as-
bias) signing patients to study groups. Subjects
were divided into 18 pairs using matched
randomization based on sex and a similar
degree of malocclusion (considering SNB,
ANB, SNGoGn, and overjet). One patient
of each pair, selected at random by tossing a
coin, was treated with FMA utilizing step-
wise advancement, while the mandible of
the other patient was progressed in a single
step.”

Allocation concealment (selection bias) Unclear risk Not reported

Blinding of outcome assessment (detection Low risk “Cephalometric measurements were per-
bias) formed in a blinded manner, i.e., the ex-
All outcomes aminer (A.P.) was unaware of the group as-
signment.”

Incomplete outcome data (attrition bias) Low risk Gp 1: recruited 18, analysed 17
All outcomes Gp 2: recruited 18, analysed 17
“Because a male patient in the SSG discon-
tinued treatment, the corresponding pa-
tient in the other group was excluded from
the final analysis to maintain a 1:1 inter-
group ratio. Data for 34 subjects were col-
lected.”

Selective reporting (reporting bias) Low risk Expected outcomes reported

Other bias Low risk No other sources of bias identified

Aras 2017b

Methods Location: Ege University, Turkey

Number of centres: 1
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: angle Class II subdivision malocclusion in the permanent dentition,
based on the presence of Class I molar relationship on one side and at least end-to-end
Class II molar relationship on the other; absence of severe crowding; normal or slightly
increased overbite; mild or moderately increased overjet; maxillary midline coincident

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 42
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Aras 2017b (Continued)

with facial midline; mandibular midline deviation to the Class II side; and no functional
lateral mandibular shift during closure (determined by clinical examination)
Exclusion criteria: none stated
Age at baseline: Gp 1: 14.19 years (SD 1.02); Gp 2: 13.75 years (SD 1.16)
Number randomised: 34 (17 in each group)
Number evaluated: 28 (6 dropouts)

Interventions Gp 1 (n = 17): Forsus group (Forsus FRD)

Gp 2 (n = 17): FMA using single-step advancement (SSG)

Outcomes Cephalometric radiographs to assess soft tissues and dentoskeletal effects

Model measurement for molar relationship and centrelines

Notes Sample size: “According to the power analysis with 0.05 level and 80% power (based on a
1.32-mm standard deviation and a 1.5-mm detectable difference for midline correction)
, the needed minimum sample size was 12 for each group.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Matched randomization was used for allo-
bias) cation of patients to the two study groups.
Subjects were divided into 17 pairs. Pa-
tients within each pair were selected so that
they had a similar degree of malocclusion
(based on overjet, molar relationship, and
crowding). One of the patients in each pair,
randomly selected through tossing a coin,
received fixed appliance treatment with the
Forsus group (Forsus FRD) whereas the
other patient received fixed appliance treat-
ment with intermaxillary elastics (elastics
group)”

Allocation concealment (selection bias) Unclear risk Not reported

Blinding of outcome assessment (detection Low risk “Appraisal of all cephalometric radiographs
bias) and digital models were carried out by one
All outcomes examiner in a blinded manner.”

Incomplete outcome data (attrition bias) Low risk “Two patients were removed from the elas-
All outcomes tics groups due to poor cooperation on elas-
tics wear. Also, after leveling and alignment,
the Class II molar relationship turned into a
Class I in one of the Forsus patients. These
and the corresponding patients in the other
group were excluded from the final analysis
to maintain the 1:1 intergroup ratio. Thus,

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 43
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Aras 2017b (Continued)

28 patients were included in the final as-

sessment”

Selective reporting (reporting bias) Low risk All relevant outcomes reported

Other bias High risk Gender bias: M:F = 8:20

“According to the power analysis with 0.
05 level and 80% power (based on a 1.32-
mm standard deviation and a 1.5-mm de-
tectable difference for midline correction)
, the needed minimum sample size was 12
for each group.”

Banks 2004

Methods Location: United Kingdom

Number of centres: 3 centres, 4 operators
Recruitment period: not stated
Funding source: British Orthodontic Society 1998 Research & Audit award
Trial design: parallel group RCT

Participants Inclusion criteria: overjet of 7 mm or more; no previous appliance therapy; permanent

dentition stage, age 10 to 14 years; and no significant medical history
Exclusion criteria: none stated
Age at baseline: mean age group 12.6 years
Number randomised: 203 (14 incorrectly included or protocol deviation), 189 started
treatment
Number evaluated: 136 (76/95 and 60/94)

Interventions Gp A (n = 95 ): Twin Block with stepwise incremental advancement

Gp B (n = 94 ): Twin Block with single step advancement

Outcomes All Cephalometric variables, duration of treatment and carstairs social deprivation score

Notes Duration of randomised treatment (months): Gp A = 7.02 (6.34 to 7.70), Gp B = 7.40

(6.71 to 8.09)
Sample size calculation: “A 20% difference between the groups in compliance rate was
thought to be clinically significant. On this basis, with alpha at 0.05 and the study power
at 0.85, we needed 80 patients per group. To allow for 20% treatment discontinuation,
we recruited over 200 patients with an intention to treat analysis.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “The patients were randomized to either
bias) the control or the experimental group”.
The randomisation was made at the start of

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 44
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Banks 2004 (Continued)

the study with pre-prepared random num-

ber tables with a block stratification on cen-
tre and sex (unpublished data)

Allocation concealment (selection bias) Low risk “We performed manual allocation using
sealed envelopes to blind the operator dur-
ing enrolment of patients in the study.”

Blinding of outcome assessment (detection Low risk “When measuring the cephalograms, the
bias) examiner was unaware of the group to
All outcomes which the patient had been allocated.”

Incomplete outcome data (attrition bias) High risk Experimental group - recruited 95, com-
All outcomes pleted 76 (loss 20%)
Control group - recruited 94, completed
60 (loss 36%)
Reasons for discontinuation not specified

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other sources of bias identified

Baysal 2014

Methods Location: Turkey

Number of centres: 1
Recruitment period: February 2007 to June 2009
Funding source: research grant from Erciyes University (SBT-07-36)
Trial design: parallel group RCT

Participants Inclusion criteria: skeletal Class II relationship (ANB > 4°); mandibular retrognathy
(SNB < 78°); overjet ≥ 5 mm; SN-GoGn = 32° ± 6°; minimal crowding in dental
arches (≤ 4 mm); bilateral Class II molar and canine relation (at least 3.5 mm); patients
with fourth (S and H2) or fifth (MP3cap, PP1cap, Rcap) epiphyseal stages on hand
wrist radiographs, as defined by Björk (1972)
Exclusion criteria: no history of orthodontic treatment either prior to or during func-
tional appliance therapy; congenitally missing or extracted permanent tooth (except third
molars); posterior crossbites or severe maxillary transverse deficiency; severe facial asym-
metry determined by clinical or radiographical examination; poor oral hygiene; systemic
diseases that may affect the orthodontic treatment results
Age at baseline: Herbst group - mean age = 12.74 years (SD = 1.43); Twin Block group
- mean age = 13.0 years (SD = 1.32); Control group - mean age = 12.17 years (SD = 1.
47)
Number randomised: 47
Number evaluated: 40

Interventions Gp A (n = 23): Herbst appliance

Gp B (n = 24): Twin Block

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 45
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Baysal 2014 (Continued)

Outcomes Cephalometric radiographs to assess soft tissues and dentoskeletal effects

Notes Duration of active treatment - 16.2 months (Twin-Block) + recruited period (2 years
and 4 months)
Sample size: the sample size for the groups was calculated based on a significance level
of 0.05 and a power of 80 per cent to detect a clinically meaningful difference of 1 mm
(± 1.5 mm) for the distance of the lower lip to E plane between the three groups. The
power analysis showed that 18 participants in each group were required

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Randomization was made at this stage
bias) according to previously prepared random
number tables with block stratification
on gender. Twenty-three patients were in-
cluded in the Herbst group and 24 patients
were enrolled in the TB group. The control
group comprised 20 subjects who refused
treatment after initial records were taken
with excuses such as college entrance ex-
amination, problems in medical insurance
system, or refusal to wear appliance.”

Allocation concealment (selection bias) Unclear risk Concealment approach not specified

Blinding of outcome assessment (detection High risk “Cephalometric tracings were performed
bias) by the same author (AB) manually.”
All outcomes

Incomplete outcome data (attrition bias) Low risk Herbst group - recruited 23, analysed 20
All outcomes (loss 13%)
TB group - recruited 24, analysed 20 (loss
16%)
Reasons for discontinuation:
Herbst group - poor oral hygiene and pro-
gression of white spot lesions (n = 1); non-
compliance (n = 1)
TB group - lost to follow up (n = 1); hos-
pitalised for a systemic disease (n = 1); no
longer wanted treatment (n = 1); poor oral
hygiene and progression of white spot le-
sions (n = 1)

Selective reporting (reporting bias) Low risk All cephalometric variables reported

Other bias Low risk No other source of bias identified

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 46
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Bilgiç 2011

Methods Location: Diyarbakir, Turkey

Number of centres: 1: Dicle University, Turkey
Recruitment period: not specified
Funding source: not specified
Trial design: parallel group

Participants Inclusion criteria: active growth period; Class II skeletal relationship due to retrognathic
mandible; increased overjet; normal or reduced incisor mandibular plane angle; well-
aligned lower arch; normal or forward growth pattern
Exclusion criteria: none specified
Age at baseline: Forsus FRD EZ group 12.31 years (SD 1.09), Activator group 12.67
years (SD 1.24)
Number randomised: 24 (12 in each group)
Number evaluated: 24

Interventions Gp A (n = 12): Forsus FRD EZ fixed functional appliance

Gp B (n = 12): Activator (Andresent-type) appliance

Outcomes All cephalometric variables reported

Notes Duration of active treatment - 6 months

Sample size: “A power test (Minitab 14.0) between pre-treatment and post-treatment
primary result variables determined that a minimum of 20 subjects was necessary for
difference comparisons.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection High risk “The patients were randomly divided into
bias) two groups” and “Patients were selected
and matched”
Method of sequence generation not de-
scribed

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Unclear risk Not described

bias)
All outcomes

Incomplete outcome data (attrition bias) Low risk No dropouts or losses to follow-up men-
All outcomes tioned. 24 randomised and 24 analysed

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other source of bias identified

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 47
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Burhan 2015

Methods Location: Damascus, Syria

Number of centres: 1. Al Baath University, Syria
Recruitment period: registered patients in pending records
Funding source: not specified
Trial design: parallel group RCT

Participants Inclusion criteria: skeletal Class II division 1 malocclusion resulting from the retrusion
of the mandible (SNB angle < 78°); convex facial profile; ANB angle > 4°; good mouth
health; no previous orthodontic treatments; pubertal growth spurt peak at the beginning
of the treatment, which was assessed using hand-wrist radiographs according to the
Fishman method
Exclusion criteria: none specified
Age at baseline: Bite Jumping Appliance group 11.5 years (SD 1.0), Twin Block 11.8
years (SD 0.9)
Number randomised: 44 (22 in each group)
Number evaluated: 40

Interventions Gp A (n = 20): Bite jumping appliance - removable functional appliance

Gp B (n = 20): Twin Block appliance - removable functional appliance

Outcomes Using cephalometric radiograms, the dentoalveolar and skeletal effects resulting from
both appliances were detected

Notes Duration of active treatment - 12 months + recruited period (not reported)

Sample size: to determine the appropriate sample size, the Minitab software was used
with two-sample t-tests, a selected study power of 80%, a significance level of 0.05, and
a detected difference of 1°. The used standard deviation (SD) of 1.09° was based on a
pilot study of 10 cases (five in each group). The appropriate sample size was 20 patients
in each group. This number was increased to 22 participants to compensate for the
potential dropouts

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk A computer-generated randomisation list

bias) was used to randomly divide the patients
into two equal groups

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Low risk Blinding of assessment was performed by
bias) (ASB) coding names of patients on pre- and
All outcomes post-treatment cephalograms, and trac-
ing and measurements were performed by
(FRN), so that the group each participant
belonged to was unknown when the records
were evaluated

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Burhan 2015 (Continued)

Incomplete outcome data (attrition bias) Low risk BJA group - recruited 22, completed 20
All outcomes (loss 10%)
TB group - recruited 22, completed 20 (loss
10%)
Reasons for discontinuation:
BJA group - failed to return for follow-up
appointments (n = 2)
TB group - failed to return for follow up
appointments (n = 1); uncooperative pa-
tients (n = 1)

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other source of bias identified

Cevidanes 2003

Methods Location: North Carolina, Brazil and Ohio

Number of centres: 1: Sao Paulo, Brazil
Recruitment period: not specified
Funding source: grants from FAPESP and CNPq, Brazil
Trial design: parallel group RCT

Participants Inclusion criteria: Class II Division 1 malocclusion, with greater than or equal to three-
fourths cusp Class II molars and overjet ranging from 4.5 mm to 10 mm
Exclusion criteria: none specified
Age at baseline: Frankel group 10.3 years (SD 0.9), untreated control group 10.9 years
(SD 0.7)
Number randomised: 56 (28 in each group)
Number evaluated: not reported

Interventions Gp A: Frankel appliance

Gp B: Untreated control

Outcomes Counterpart analysis using cephalogram. Measurements included:

• mandibular retrusive/protrusive effects;
• middle cranial fossa and posterior maxilla relative alignment;
• ramus alignment;
• ramus/middle cranial fossa relative to posterior maxilla vertical dimension;
• gonial angle.

Notes Duration of randomised treatment 18 months

Sample size calculation not reported

Risk of bias

Bias Authors’ judgement Support for judgement

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Cevidanes 2003 (Continued)

Random sequence generation (selection Unclear risk “Class II children were randomly allocated
bias) to 2 subgroups, treated and control, to
avoid bias in the group comparison.”
Method of sequence generation not re-
ported

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Low risk “Tracings were performed with blinding
bias) procedure.”
All outcomes

Incomplete outcome data (attrition bias) Unclear risk 2-phase trial. Unclear data. Number of chil-
All outcomes dren evaluated at 18 months not stated

Selective reporting (reporting bias) Unclear risk The authors have not reported regular
cephalometric variables. They have done
counterpart analysis which does not in-
clude regular cephalometric measurements

Other bias Unclear risk Baseline characteristics (gender) not re-

ported

Cirgi 2016

Methods Location: general dental practices (GDP) in Sweden

Number of centres: 12 general dental practices at the Public Dental Health Services,
Region Västra Götaland
Recruitment period: 2007 to 2010. “However, it took long time to recruit patients so
we decided to stop when 105 participants were involved in the study.”
Funding source: The Council for Research and Development in the Västra Götaland
Region, Gothenburg Dental Society and Swedish Dental Society
Trial design: parallel group RCT

Participants Inclusion criteria: 6 to 14 years old with central incisors erupted, Angle Class II division 1,
increased overjet ≥ 6 mm or less if lip incompetence was present, no previous orthodontic
treatment
Exclusion criteria: crossbite, severe crowding, agenesis, other malocclusions
and syndromes
Age at baseline: 97 participants (44 girls, 53 boys), mean age was 10.3 years (SD 1.64;
range 7 to 14 years)
Number randomised: 105
Number evaluated: 97

Interventions Gp 1 (n = 40): modified Andresen activator (AA)

Gp 2 (n = 57): prefabricated functional appliances (PFAs)

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Cirgi 2016 (Continued)

Outcomes Overjet change, molar relationship, overbite and lip seal, treatment time and success rate

Notes “According to a sample size analysis, 38 patients per group were required to obtain
adequate power (80 per cent, at significance level P < 0.05 with an standard deviation
(SD) of 1.3 and with the loss of 10 patients), based on a clinically significant difference
of 1 mm in overjet reduction between the study groups.”
“No harms were detected during the study.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk “Patients were randomly allocated by lot-
bias) tery”
“As we expected a high risk of dropouts and
non-compliant patients, as seen in previ-
ous studies we aimed for 240 patients in
total, compared with 76 patients required
according to sample size analysis. However,
it took long time to recruit patients so we
decided to stop when 105 participants were
involved in the study. This was the reason
for the uneven randomization.”

Allocation concealment (selection bias) Unclear risk “At each clinic two envelopes were available
one for girls and one for boys with 5 AA
and 5 PFA notes for each gender.”

Blinding of outcome assessment (detection High risk “Blinding was not performed”
bias)
All outcomes

Incomplete outcome data (attrition bias) Unclear risk Clinical measurements: 105 recruited; 97
All outcomes randomised and reported. Gp 1: 62 ran-
domised and 57 (85%) reported; Gp 2: 43
randomised and 40 (87%) reported
For the questionnaire Gp 1: 40 randomised
and 20 analysed (50%), Gp 2: 57 ran-
domised and 24 reported (42%)

Selective reporting (reporting bias) Low risk All variables reported

Other bias Unclear risk Uneven randomisation. “As we expected

a high risk of dropouts and non-compli-
ant patients, as seen in previous studies we
aimed for 240 patients in total, compared
with 76 patients required according to sam-
ple size analysis. However, it took long time

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cirgi 2016 (Continued)

to recruit patients so we decided to stop

when 105 participants were involved in the
study. This was the reason for the uneven
randomization.”

Cura 1997

Methods Location: Turkey

Number of centres: 1
Recruitment period: not stated
Funding source: University of Istanbul Research Fund
Trial design: parallel group RCT

Participants Inclusion criteria: children with Class II Division 1 malocclusion, defined by Class II
molar relationship and ANB difference of 5°
Exclusion criteria: poor co-operation
Age at baseline: 11 years
Number randomised: 60 (35 and 25 to Bass and control groups)
Number evaluated: 47 (27/35 and 20/25 respectively)

Interventions Gp A (n = 27): Bass functional appliance

Gp B (n = 20): untreated control

Outcomes Skeletal discrepancy measured by ANB on cephalogram, skeletal development

Notes Duration of randomised treatment: 6 months

Sample size calculation: not reported

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk “The sample was randomly divided into a
bias) treatment group of 35 cases and a control
group of 25 cases.”
Method of sequence generation not de-
scribed

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Unclear risk Blinded assessment not reported
bias)
All outcomes

Incomplete outcome data (attrition bias) High risk 13 dropouts (22%). 8/35 participants in
All outcomes treatment group and 5/25 in control group.
Reasons given - poor co-operation and lack
of communication

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cura 1997 (Continued)

Dropout participants not included in anal-

ysis, but percentage similar in each group

Selective reporting (reporting bias) Low risk All outcome variables reported

Other bias High risk Gender imbalance at baseline

Eissa 2017

Methods Location: Tanta, Egypt

Number of centres: 1
Recruitment period: not reported
Funding source: not reported
Trial design: parallel group RCT

Participants Inclusion criteria: skeletal Class II malocclusion with mandibular retrognathia (ANB >
4.5, SNB > 76); normal vertical growth pattern (SN-MP angle in 258 to 358 range);
minimal or no crowding in the mandibular arch (0 to 5 mm), based on Little’s irregularity
index; no extracted or missing permanent teeth (third molars excluded); undergoing
circumpubertal phase of skeletal development (CVMI 2 to 4); no medical history or
systemic disease that could affect normal growth of the body or jaws
Exclusion criteria: not reported
Age at baseline: Gp 1: 12.76 (SD 1.0); Gp 2: 12.52 (SD 1.12); Gp 3: 12.82 (SD 0.9)
Number randomised: 45
Number evaluated: 38

Interventions Gp 1: conventional FRD

Gp 2: miniscrew-anchored FRD
Gp 3: untreated control

Outcomes All cephalometric variables, success rate for screws and harms

Notes “Sample size calculation was based on the ability to detect a clinically meaningful differ-
ence in mandibular length of 2 mm (6 1.5 mm), with an alpha error of 0.05 and a test
power of 80%. The calculation was carried out using software G* Power (Universitat
Dusseldorf, Germany). The recommended sample size was 12 patients in each group.
To compensate for a possible dropout rate of 20% during the study period, 15 patients
were included in each group.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Patients were randomly assigned using a
bias) computer generated random list.”

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Eissa 2017 (Continued)

Allocation concealment (selection bias) Low risk “The patients were randomly allocated into
three groups using sequentially numbered,
opaque, sealed envelopes.”

Blinding of outcome assessment (detection Unclear risk “...the investigator who analyzed the
bias) cephalograms was blinded regarding the
All outcomes origin of the films and the group to which
the individual subjects belonged. All data
were labeled with numbers and sent to the
statistician, who was also blinded to the pa-
tients’ groups. For the control group, it
was impossible to be completely blinded
as there were no appliances in the patients’
mouths, but blinding was achieved regard-
ing the time point of the cephalograms.”

Incomplete outcome data (attrition bias) Unclear risk Gp 1: recruited 15, analysed 14
All outcomes Gp 2: recruited 15, analysed 15
Gp 3: recruited 15, analysed 9
Uneven dropout rate between groups

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other source of bias identified

Elkordy 2016

Methods Location: Cairo, Egypt

Number of centres: 1
Recruitment period: from June 2012 to December 2013
Funding source: self-funded by the authors
Trial design: parallel group RCT

Participants Inclusion criteria: females 11 to 14 years old; skeletal angle Class II division 1 malocclu-
sion with a deficient mandible (SNB ≤ 76°); horizontal or neutral growth pattern (MMP
≤ 30°); increased overjet (minimum 5 mm) with Class II canine relationship (minimum
of half unit); erupted full set of permanent teeth with mandibular arch crowding less
than 3 mm; at the time of insertion of the FFRD, the patients had to be in the MP3 G
or MP3 H stage according to Rajagopal
Exclusion criteria: systemic disease; any signs or symptoms of temporomandibular dys-
function; extracted or missing permanent tooth/teeth; facial asymmetry; parafunctional
habits; severe proclination or crowding that requires extractions in the lower arch
Age at baseline: FFRD 16 females (13.25 SD 1.12); FMI 15 females (13.07 SD 1.
41); control (12.71 SD 1.44)
Number randomised: 46
Number evaluated: 43

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Elkordy 2016 (Continued)

Interventions Gp A (n = 16/16): Forsus Fatigue Resistance Device (FFRD)

Gp B (n = 15/15): Forsus Fatigue Resistance Device with mini-implant (FMI)
Gp C (n = 15/12): control/no intervention

Outcomes (i) Overjet

(ii) Skeletal changes
(iii) Dentoalveolar changes
(iv) Patient satisfaction

Notes Duration of randomised treatment:

• FFRD
4.86 (SD 1.32)
• FMI
5.34 (SD 1.29)
Sample size calculation: sample size calculation was done using G power software (Uni-
versität Düsseldorf, Düsseldorf, Germany), with an alpha value of 0.05 and a power of
80% based on the study by Weschler and Pancherz and revealed the need for 12 partic-
ipants per group

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “A computer-generated random list was
bias) created ([Link]
patients were randomly allocated into three
groups...”
The control group arm was not reported in
the first part of the study

Allocation concealment (selection bias) Low risk “...and allocation concealment was
achieved with opaque sealed envelopes.”

Blinding of outcome assessment (detection Low risk “The assessors were blinded during the
bias) analysis.”
All outcomes

Incomplete outcome data (attrition bias) Unclear risk Gp A - Forsus Fatigue Resistance Device
All outcomes (FFRD) recruited 16, analysed 16 (loss 0%)
Gp B - Forsus Fatigue Resistance De-
vice with mini-implant (FMI) recruited 15,
analysed 15 (loss 0%)
Gp C - control/no intervention recruited
15, analysed 12 (loss 20%)
Reasons for discontinuation in control
group:
“Two of the control patients wanted to start
treatment immediately, and a third could

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Elkordy 2016 (Continued)

not be reached after 3 months”

Selective reporting (reporting bias) Low risk All variables reported

Other bias Unclear risk The sample comprised 32 females.

Florida 1998

Methods Location: University of Florida, USA

Number of centres: 1
Recruitment period: not stated
Funding source: funded by NIH (DE08715)
Trial design: parallel group RCT over 10 years

Participants Inclusion criteria: third or fourth grade at school, at least bilateral 1/2 cusp Class II
molars or 1 side < 1/2 cusp Class II if other side greater than 1/2 cusp Class II. Fully
erupted permanent first molars, emergence of not more than 3 permanent canines or
premolars and positive overbite and overjet
Exclusion criteria: not willing to undergo orthodontic treatment or to be randomly
allocated to treatment type. Poor general health, active dental or periodontal pathology
Age at baseline: mean 9.6 years
Screened child population (360) then referred to clinic for treatment
Number randomised: 325 randomised, 277 started treatment: 95, 100 and 82 in bion-
ator, headgear and control respectively
Number evaluated: end of treatment phase (I) 79/95, 92/100, 78/82; end of retention
phase 75/95, 85/100 and 75/82; and end of follow-up (II) 70/95, 81/100, 74/82 in
bionator, headgear and control groups respectively

Interventions Gp A: Bionator appliance

Gp B: Cervical pull headgear with removable bite plane
Gp C: Delayed treatment control
3 phases of treatment: 2 years of early treatment plus 6 months retention plus further 6
months follow-up

Outcomes (i) Overjet

(ii) Skeletal discrepancy
(iii) Dental alignment measured with the PAR index

Notes Duration of randomised treatment: 2 years initially

Sample size calculation not reported

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection High risk A stratified block randomisation procedure
bias) was used:
“Subjects initially were selected in blocks of

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Florida 1998 (Continued)

six and randomized to the treatment pro-

tocols. This procedure of assigning subjects
to groups only after a block had filled was
modified in year 3, after we recognised slow
entry rate and many partially filled blocks
(23% of the sample) were randomized to
groups.”

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Low risk “All cephalometric radiographs were en-
bias) coded by the staff assistant and then de-
All outcomes coded for analysis.”

Incomplete outcome data (attrition bias) High risk Clear information on withdrawals. Drop-
All outcomes outs: 24%. Number of dropouts approxi-
mately equal in each group but rate of with-
drawal was significantly higher for non-
whites

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other sources of bias identified

Ghafari 1998

Methods Location: The University of Pennsylvania, USA

Number of centres: 1
Recruitment period: not stated
Funding source: this study was supported by grants RO1-DE08722 and RR-00040
(NIH)
Trial design: parallel group RCT

Participants Inclusion criteria: Class II, Division 1 malocclusion associated with bilateral distocclusion
(unilateral Class I excluded) and a minimum ANB angle of 4.5°; between 7 and 12.5/
13 years of age; no prior orthodontic treatment; and expected residential stability of 3
years
Exclusion criteria: children with systemic, mental, behavioural, bleeding, and craniofacial
disorders were excluded. If siblings presented with the same malocclusion, only 1 of them
was recruited because they share in both the genetic background and environment
Age at baseline: chronological age range 7 years 2 months to 13 years 4 months. Skeletal
age range at baseline 5 years 9 months to 13 years 9 months and was basis of grouping
participants into early (< 10 years for girls and < 10.5 years for boys) and late childhood
Number randomised: 84
Number evaluated: 63

Interventions Gp A (n = 35/41): headgear - straight pull headgear inserted into the buccal tubes of
bands cemented on permanent maxillary front molars
Gp B (n = 28/43): Frankel function regulator type II to be worn at least 16 hours per

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Ghafari 1998 (Continued)

day

Outcomes Skeletal measurements from cephalograms, occlusal changes

Notes Duration of randomised treatment: 2 years

Sample size calculation: not specified

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomised. “Within each severity group,
bias) the children were assigned at random to
treatment with either a headgear (n = 41)
or a Frankel FR (n = 43).”
Sequence generation method not described

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Unclear risk Not described

bias)
All outcomes

Incomplete outcome data (attrition bias) High risk “Non cooperative children were those pa-
All outcomes tients who, at some point in time, refused
to receive treatment, despite all efforts to
retain them. The largest percentage of these
children were girls who wore the Fränkel
regulator (42%); by contrast, the small-
est number discontinued were girls in the
headgear group (5%). The difference be-
tween these two groups of girls was statis-
tically significant (P < 0.05). The percent-
ages of boys lost to the study were similar in
the headgear (24%) and FR (25%) groups.
”
Dropouts in headgear 6/41 (15%), Frankel
15/43 (35%). This statistically significant
difference between groups is likely to intro-
duce bias

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other sources of bias identified

Complete set of data not reported. Data for
only 26/84 participants reported

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Jamilian 2011

Methods Location: University of Islamic Azad and Shahid Beheshti, Tehran, Iran
Number of centres: not specified
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: ANB > 4°, SNB < 78° degrees, overjet ≥ 5 mm at the start of treatment,
no syndromic or medically compromised patients, no previous surgical intervention, no
use of other appliances before or during the period of functional treatment, a normal
mandibular growth pattern: neither horizontal nor vertical, no skeletal asymmetry
Age at baseline: R-appliance group 10.5 (SD 0.7) years and Twin Block group 11.3 (SD
1.3) years
Number randomised: 55
Number evaluated: 55 (no dropouts)

Interventions Gp A (n = 30): R-appliance Tooth- and tissue-born functional appliance worn full
time
Gp B (n = 25): Twin Block appliance with upper labial bow worn full time

Outcomes Skeletal measurements from cephalograms, occlusal changes

Notes Duration of randomised treatment: R-appliance 16.2 months (SD 0.3) months, Twin
Block appliance 16.1 (SD 1.4) months
Sample size calculation: not specified

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Randomised. “...patients were randomly
bias) divided to two groups using random num-
ber tables” (unpublished data)

Allocation concealment (selection bias) Unclear risk Allocation concealment not clearly de-
scribed. “Specific codes were assigned to
each patient for their concealment” (un-
published data)

Blinding of outcome assessment (detection Low risk Outcome assessors were blinded (unpub-
bias) lished data). However, the method of blind-
All outcomes ing was not described

Incomplete outcome data (attrition bias) Low risk No dropouts

All outcomes

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other bias detected

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Jin 2015

Methods Location: Department of Orthodontics, Shenyang Stomatological Hospital, China

Number of centres: not specified
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: dissolution, slightly dentition crowding, maxillary protrusion,

mandibular retrusion, ANB > 5°, low angle or medium mandibular plane angle
Age at baseline: straight wire appliance 12.34 years and Twin Block group 12.05 years
Number randomised: 30
Number evaluated: 30 (no dropouts)

Interventions Gp A (n = 15): straight wire appliance

Gp B (n = 15): Twin Block appliance

Outcomes Skeletal and soft tissues measurements from cephalograms

Notes Duration of randomised treatment: from 2006 to 2008

Sample size calculation: not specified

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Randomised. “30 patients were divided
bias) into 2 groups according to the random
number table method (15 patients per
group)”

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Unclear risk Outcome assessors blinding not described
bias)
All outcomes

Incomplete outcome data (attrition bias) Low risk No dropouts

All outcomes

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other bias detected

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Lee 2007

Methods Location: London, UK

Number of centres: 1
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: Class II Division 1 malocclusion, minimum overjet of 7 mm, mandibu-
lar retrognathia contributing to the Skeletal II pattern as assessed clinically. Male Cau-
casians aged 11 to 14 years and female Caucasians aged 10 to 13 years
Exclusion criteria: previous orthodontic treatment or extraction of permanent teeth
Age at baseline: 28 males 12 to 14.7 years, 34 females 10.6 to 13.7 years
Number randomised: 62
Number evaluated: 56

Interventions Gp A (n = 31): Twin Block without upper labial bow. Blocks designed to interlock at
inclination of approximately 70°
Gp B (n = 31): Dynamax functional appliance

Outcomes Skeletal discrepancy measured by cephalometric radiographs, soft tissue changes mea-
sured by optical surface laser scanner

Notes Duration of randomised treatment: 9 months

Sample size calculation: “The recruitment of 62 subjects allowed the creation of 31
matched pairs who were subsequently randomly allocated. This was the minimum num-
ber of patients required to satisfy the statistical power calculation.”
Email sent to authors requesting clarification of sequence generation procedure. No reply
to date

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk “...patients were matched for gender and
bias) age and then randomly allocated to an ap-
pliance group by a non-clinician”
Method of sequence generation not re-
ported

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection Unclear risk Not specified

bias)
All outcomes

Incomplete outcome data (attrition bias) Low risk 6 participants failed to complete trial. 3
All outcomes in Twin Block group and 3 in Dynamax
group. Reasons not specified

Selective reporting (reporting bias) Low risk All variables reported

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Lee 2007 (Continued)

Other bias Unclear risk “A higher percentage of subjects were

found to present with appliance breakages
in the Dynamax group (55%) than in the
Twin Block group (35%).”

London 1998

Methods Location: London, UK

Number of centres: 1
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT (3 interventions randomly allocated)

Participants Inclusion criteria: children aged 8 to 15 years old with Class II Division 1 malocclusion
and an overjet greater than 7 mm. Moderate Skeletal II base relationship with mandibular
retrognathia
Exclusion criteria: previous orthodontic therapy or extraction of permanent teeth, or
significant adverse medical history
Age at baseline: mean 12 years
Number randomised: 58 (18, 21, 19 to Gps A, B and C respectively)
Number evaluated: 47 (13, 18, 16 from Gps A, B and C respectively)

Interventions Gp A (n = 13): Bass appliance

Gp B (n = 18): Bionator appliance
Gp C (n = 16): Twin Block appliance

Outcomes (i) Overjet

(ii) Skeletal discrepancy ANB method unclear
(iii) Soft tissue variables

Notes Duration of randomised treatment: 9 months

Sample size calculation: not reported. Numbers of participants completing trial are very
small and trial likely to be underpowered

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomised to treatment groups and con-
bias) trol group not randomised
Method of sequence generation not de-
scribed

Allocation concealment (selection bias) Unclear risk Unclear

Blinding of outcome assessment (detection Unclear risk Not reported

bias)
All outcomes

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London 1998 (Continued)

Incomplete outcome data (attrition bias) High risk Clear information on withdrawals. Drop-
All outcomes outs: 19%. 58 enrolled and 47 completed
Dropouts 5 (27%), 3 (15%) and 3 (17%)
in Bass, Bionator and Twin Block group
respectively. Reasons not reported

Selective reporting (reporting bias) Low risk All variables reported

Other bias Unclear risk Differences in age at baseline between ran-

domised groups. Not statistically signifi-
cant but this may be due to small numbers
in each group

Mao 1997

Methods Location: China

Number of centres: 1
Recruitment period: from 1994
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: children aged 8 to 11 years old with Class II Division 1 malocclusion
Exclusion criteria: not stated
Age at baseline: range 8 to 11 years mean 9.5 years
Number randomised: 52
Number evaluated: 52

Interventions Gp A (n = 26): Bionator/headgear appliance

Gp B (n = 26): no orthodontic treatment

Outcomes Skeletal discrepancy measured by ANB, occlusion. Reporting of outcomes unclear

Notes Duration of randomised treatment: unclear

Sample size calculation: not reported

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Randomly allocated. “The 52 children
bias) were randomly divided into two groups,
treated group (n = 26, 18 males and 8 fe-
males) and untreated group (n = 26, 9 males
and 17 females).”
Method of sequence generation not speci-
fied

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Mao 1997 (Continued)

Allocation concealment (selection bias) Unclear risk Not reported

Blinding of outcome assessment (detection Unclear risk Unclear on blinding

bias)
All outcomes

Incomplete outcome data (attrition bias) Unclear risk Dropouts not specified
All outcomes

Selective reporting (reporting bias) Unclear risk Reporting of data not clear

Other bias High risk Data reported unclear. Groups very differ-
ent at baseline (Bionator group 18 males,
6 females and untreated group 9 males and
17 females)

Martina 2013

Methods Location: Italy

Number of centres: 1
Recruitment period: April 2006 to June 2007
Funding source: Italian Ministry of University and Research
Trial design: parallel group RCT

Participants Inclusion criteria: ”Full class II molar relationships, overjet ≥ 6 mm, an age range of 10-
13 years for boys and of 9-12 years for girls“
Exclusion criteria: ”Cervical vertebral maturation stage (CVMS) <2 or >3 (25), lack of
parent’s willingness to sign an informed consent form, sella-nasion to mandibular plane
(Me-Go) angle equal to or greater than the normal value plus a standard deviation,
periodontal diseases, orofacial inflammatory conditions, tooth agenesis, congenital syn-
dromes, and previous orthodontic treatment
Age at baseline: range 10 to 13 years for boys and 9 to 12 years for girls
Number randomised: 61
Number evaluated: 46

Interventions Gp A (n = 23): Sander Bite jump appliance

Gp B (n = 23): no orthodontic treatment

Outcomes Dentoalveolar, sagittal, and vertical changes assessed trough cephalometric analysis

Notes Duration of randomised treatment: 18 months (BJA) and 12 months (control group)
Sample size calculation: “The determination of sample size was based upon previous
estimates of changes in mandibular length (Pg/OLp) during growth. By setting type I
error at 0.05 and type II error at 0.20 (80% power), it was found that at least 19 patients
per group were needed to detect an increase in mandibular length ≥ 2.0 mm”

Risk of bias

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Martina 2013 (Continued)

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Enrolled patients were allocated to either a
bias) treatment (BJA) or control (CTR) group by
balanced block randomization using gen-
der as a stratifying factor. A custom-made
Java script was used to generate the ran-
domization procedure by a single investiga-
tor (SP) that was not involved in the clinical
management of patients and control sub-
jects.”

Allocation concealment (selection bias) Low risk “The randomization sequence was carefully
concealed to the other investigators and was
disclosed immediately after obtaining writ-
ten informed consent. Patients allocated
to the BJA group were treated with the
BJA, whereas patients allocated to the CTR
group did not receive any treatment and
acted as passive controls.”

Blinding of outcome assessment (detection Low risk “A single operator (IC), who was blinded
bias) to patient allocation (i.e. the allocation was
All outcomes masked to him in the dataset) performed
the statistical analyses.”

Incomplete outcome data (attrition bias) High risk Gp A - BJA recruited 31, analysed 23 (loss
All outcomes 25%)
Gp B - control recruited 30, analysed 23
(loss 23%)
Reasons for discontinuation:
BJA group - did not receive allocated inter-
vention (n = 6; 4 not willing to go further
in the trial, 2 transferred); lost to follow-up
(n = 2)
Control group - lost to follow-up (n = 7)

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other bias found

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
New Zealand 2000

Methods Location: New Zealand

Number of centres: 1
Funding source: Medical Research Council of New Zealand
Trial design: parallel group RCT (3 groups)

Participants Inclusion criteria: children in clinic with Class II Division 1 malocclusion

Exclusion criteria: none specified
Age at baseline: range 10 to 13 years, mean age (boys) 11.28 (SD 0.91) and girls 11.89
(SD 0.68)
Number randomised: 50 (18 ’triads’)
Number evaluated: 42 (12, 13, 17 in Gps A, B and C respectively)

Interventions Gp A: Harvold Activator functional appliance

Gp B: Frankel functional regulator (FR-2)
Appliances to be worn for 14 hours per day (times of wearing slowly increased over first
month of treatment)
Gp C: untreated control group

Outcomes (i) Change in skeletal pattern; (ii) Change in overjet; (iii) PAR score
ANB was not reported

Notes Duration of randomised treatment: 18 months

Sample size calculation: “The study was large enough to have a power of about 80% of
detecting a 1 standard deviation difference with P < 0.05.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk “...were matched in triads according to age
bias) and sex and randomly assigned to either
the control group (C), the Frankel function
regulator group (FFR), or the Harvold ac-
tivator group (HA)”
Method of sequence generation not de-
scribed

Allocation concealment (selection bias) High risk Not described. Allocation likely to be pre-
dictable within each group of 3

Blinding of outcome assessment (detection Unclear risk Not reported

bias)
All outcomes

Incomplete outcome data (attrition bias) High risk 50 enrolled and 42 completed. Dropouts:
All outcomes 16%
Reasons for dropouts reported “Six chil-
dren were removed from the study because
they either repeatedly failed appointments

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New Zealand 2000 (Continued)

or refused to wear the appliance as in-

structed. Two children moved to another
region.” All dropouts from the 2 treatment
groups. 5/17 (29%) from Activator group
and 3/16 (19%) from Frankel group

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk Groups similar at baseline for age group
and gender

North Carolina 2004

Methods Location: USA

Number of centres: 1
Recruitment period: August 1988 to November 1993
Funding source: grants from NIH, and Orthodontic Fund, Dental Foundation of North
Carolina
Trial design: parallel group RCT with 2 treatment phases

Participants Inclusion criteria: children with mixed dentition, with all permanent teeth developing,
with growth potential throughout phase 1 of treatment. Overjet > 7 mm, all incisors
erupted, second molars not erupted
Exclusion criteria: clinically obvious facial asymmetry, cleft or syndrome patients, more
than 2 standard deviations from normal vertical proportionality, and those with prior
orthodontic treatment
Age group: mean 9.4 years (SD 1.0)
Screened child population (2164) then referred to clinic for treatment
Number randomised: 192 randomised, 175 started treatment
Number evaluated: 53, 52, 61 at the end of phase 1, and 39, 47, 51 at the end of phase
2 for bionator, headgear and control groups respectively

Interventions Gp A (n = 53): functional appliance modified bionator with the bite taken with 4 mm
to 6 mm of protrusion and minimal vertical opening. Reactivation of appliance when
necessary was by construction of a new appliance
Gp B (n = 52): headgear - combination headgear with supershort outer bow, adjusted
to deliver 8 to 10 ounces to the headcap, with neck strap force just sufficient to prevent
buccal flaring of upper molars
All appliances delivered within 1 month of patient’s initial records being taken
Gp C (n = 61): control (observation only)

Outcomes Skeletal growth changes; maxilla, mandible, skeletal relationship, dental relationship

Notes Duration of intervention: phase 1 - 15 months; and phase 2 - 25.5, 30.1 and 34.5 for
functional, headgear and control group
Frequency of treatment visits: every 6 to 8 weeks for active treatment groups and every
6 months for control group
Sample size calculation: sample size of 40 per group was calculated as necessary to detect

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North Carolina 2004 (Continued)

a mean difference between any 2 groups equivalent to the doubling in annualised change
of SNPg (with alpha = 0.01 and power = 0.90)
Patients were re-randomised at the end of phase 2 for different clinicians

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Randomization was performed within
bias) gender in blocks of six patients with Proc
Plan in SAS”

Allocation concealment (selection bias) Unclear risk Not described

Blinding of outcome assessment (detection High risk Because the molar bands were not removed
bias) at the end of phase 1, the technician was
All outcomes not masked as to the treatment groups of
these participants

Incomplete outcome data (attrition bias) Unclear risk Number of participants randomised in dif-
All outcomes ferent groups not reported
192 randomised, 175 started, 166 finished
phase 1 and 137 finished phase 2
Dropout rate of 13.5% (low risk) for phase
1 and 28.6% (high risk) for phase 2. Rea-
sons for dropouts reported, but not for each
treatment group

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other bias found

Showkatbakhsh 2011

Methods Location: Tehran, Iran

Number of centres: not specified
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: ANB > 4°, SNB < 78°, overjet > 5 mm in the initial lateral cephalogram.
No syndromic or medically compromised patients, no surgical intervention, no use of
other appliances before or during the period of functional treatment, normal growth
pattern of the mandible (MP-SN), symmetric relationship between maxilla and mandible
Exclusion criteria: not stated
Age at baseline: R-appliance mean age 10.4 (SD 0.8). Anterior Inclined Bite Plate (AIBP)
9 (SD 1.2) years
Number randomised: 50 randomised, 50 started treatment

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Showkatbakhsh 2011 (Continued)

Number evaluated: 50 at the end of functional phase (no dropouts) (unpublished data)

Interventions Gp A (n = 25): R-appliance

Gp B (n = 25): Anterior Inclined Bite Plate (AIBP)

Outcomes Skeletal growth changes; maxilla, mandible, skeletal relationship reported. Dental mea-
surements were not reported

Notes Duration of intervention: Gp A (R-appliance): 11 (SD 2) months. Gp B: 9 (SD 1.2)

months
Sample size calculation: not specified

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “Patients were randomly assigned to two
bias) groups using standardised random number
table”

Allocation concealment (selection bias) Unclear risk Not specified

Blinding of outcome assessment (detection Unclear risk Not stated

bias)
All outcomes

Incomplete outcome data (attrition bias) Low risk No dropouts

All outcomes

Selective reporting (reporting bias) Unclear risk Only skeletal measurements reported. No
linear dental measurements reported

Other bias Low risk No other bias detected

Thiruvenkatachari 2010

Methods Location: United Kingdom

Number of centres: 2
Recruitment period: January 2008 to January 2009
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: children aged 10 to 14 years with overjet greater than 6 mm
Exclusion criteria: craniofacial syndrome, previous orthodontic treatment or premolar
extractions
Age group: not stated
Number randomised: 64
Number evaluated: 64

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Thiruvenkatachari 2010 (Continued)

Interventions Gp A (n = 32): Twin Block appliance

Gp B (n = 32): Dynamax appliance
Participants were asked to wear appliances 24 hours per day except during contact sports
and swimming

Outcomes Skeletal measurement from cephalometric radiographs. Clinical measure of overjet. Ap-
pliance breakages and adverse events

Notes Duration of randomised treatment: Trial stopped early based on planned interim analysis
Sample size calculation: “The sample size calculation was based on the data from a
previous investigation into the effectiveness of the Twin-block and Herbst appliances.
We considered that a minimum clinically meaningful difference in treatment duration
between 2 competing treatments was 4 months (common SD 4.61). For a trial with a
power of 80% and an alpha of 0.05, a sample of 32 patients in each group was required,
with an estimated noncompliance rate of 30%.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Central randomisation allocation and allo-
bias) cation by a computer using minimisation
software
“Patients were then allocated by using min-
imization to one of the treatments by using
MINIM software, with sex as a prognostic
factor.”

Allocation concealment (selection bias) Low risk Allocation carried out using central tele-
phone line and performed by people inde-
pendent from the trial

Blinding of outcome assessment (detection Unclear risk Overjet measurements done by clinicians
bias) and blinding was not possible
All outcomes DMC assessors and trial statistician
blinded to treatment allocation

Incomplete outcome data (attrition bias) Unclear risk Trial stopped early due to adverse events
All outcomes and clinical improvement
7/32 Twin Block participants and 3/32 Dy-
namax participants dropped out of the trial
Reasons for dropouts: 9 failed to attend
the follow-up appointment and 1 required
headgear

Selective reporting (reporting bias) Low risk Not all outcome variables (cephalometric
data) assessed due to premature termina-
tion

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Thiruvenkatachari 2010 (Continued)

Other bias High risk Trial stopped early based on interim analy-
sis

UK (11-14) 2003

Methods Location: United Kingdom

Number of centres: 13 centres
Recruitment period: March 1997 to June 1998
Funding source: Medical Research Council (99410454)
Trial design: parallel group RCT

Participants Inclusion criteria: children aged 11 to 14 with overjet greater than 7 mm, and second
premolars erupted
Exclusion criteria: craniofacial syndrome
Age at baseline: Gp A mean 12.41 (95% CI 12.17 to 12.63), Gp B 12.74 (95% CI 12.
48 to 12.99)
Number randomised: 215
Number evaluated: 183

Interventions Gp A: Twin Block appliance

Gp B: Herbst appliance
Participants were requested to wear the appliances 24 hours per day except during contact
sports or swimming. Treatment with functional appliances was followed by treatment
with fixed appliances if necessary

Outcomes (i) Overjet

(ii) Skeletal discrepancy measured by Pancherz analysis
(iii) Dental alignment measured with the PAR index
(iv) Duration of treatment

Notes Duration of intervention: as required to reduce overjet. Gp A = 11.22 (9.58 to 12.86),

Gp B = 5.81 (5.13 to 6.48)
Sample size calculation: “We based our sample size calculation for the number of pa-
tients necessary to achieve 80% power with an alpha of 0.05 on a clinically meaningful
difference in peer assessment rating (PAR) scores of 15% between the study groups. The
calculation showed that we needed to recruit 80 patients into each arm of the study to
account for an estimated non-completion rate of 15%.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “...the patient was randomized to receive
bias) treatment with either a Twinblock or a
Herbst appliance. ....At the beginning of
the study, random number tables were used
to prepare randomization lists, stratified by
centre and sex into permuted blocks.”

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UK (11-14) 2003 (Continued)

Allocation concealment (selection bias) Low risk Randomisation performed using a central
telephone line

Blinding of outcome assessment (detection Low risk “Cephalograms and study casts were both
bias) scored with the examiner unaware of the
All outcomes group to which the patient had been allo-
cated.”

Incomplete outcome data (attrition bias) High risk 215 enrolled and 183 evaluated. 25/110
All outcomes (23%) lost in Twin Block group and 7/105
(7%) in Herbst appliance group. Reasons
for dropouts specified (unpublished data)
. Dropouts significantly different between
groups
Herbst group: 5 had problems with appli-
ance and discontinued, 1 moved away/lost
to follow-up
Twin Block group: 14 had multiple DNAs
and were discharged with no follow-up
records, 5 moved away/lost to follow-up, 5
refused to wear the appliance, 1 fitted with
wrong appliance

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk Groups appear similar at baseline

UK (Mixed) 2009

Methods Location: United Kingdom

Number of centres: 13 centres
Recruitment period: March 1997 to August 1999
Funding source: Medical Research Council (G9410454)
Trial design: randomised parallel group trial

Participants Inclusion criteria: children in the mixed dentition with overjet greater than 7 mm, and
willingness of the patient and a parent to participate in the study. Participants had to be
in the mixed dentition with at least the permanent incisors and first molars erupted, but
there was no age criterion
Exclusion criteria: craniofacial syndromes
Age at baseline: the average age was 9.7 (SD 0.98) years for the treatment group and 9.
8 (SD 0.94) years for the control group
Number randomised: 174
Number evaluated: 127

Interventions Gp A: Twin Block early treatment: randomised 89, completed 67

Gp B: Twin Block delayed treatment: randomised 85, completed 73

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 72
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UK (Mixed) 2009 (Continued)

Outcomes (i) Overjet

(ii) Skeletal discrepancy measured by Pancherz analysis
(iii) Dental alignment measured with the PAR index
(iv) Sociopsychological effects of treatment

Notes Duration of intervention: 15 months

Sample size calculation: “This showed that the mean duration of treatment for patients
who had later treatment after early treatment was 25 months (SD 11). It was decided
that a meaningful difference between the treatment duration for children who did, or
did not, receive early treatment was 6 months. To give a study a power of 80% and an
alpha of 0.05, the sample size needed to be 60 in each group.”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “The randomization was made at the start
bias) of the study with pre-prepared random
number tables with a block stratification on
centre and sex.”

Allocation concealment (selection bias) Low risk Randomisation carried out using a central
telephone line and minimisation software

Blinding of outcome assessment (detection Low risk Assessor blinded to outcomes. “The
bias) cephalograms and the study casts were
All outcomes scored with the examiner unaware of the
patient’s group.”

Incomplete outcome data (attrition bias) Low risk Clear information on withdrawals, but
All outcomes rates different in each group. 22/89 (25%)
in the Twin Block group and 12/85 (14%)
in the control group
Reasons for exclusion specified (unpub-
lished data)
Control group: 4 refused to consent for
phase 2 treatment, 1 withdrew due to ill-
ness, 3 had multiple DNAs with no final
records, 1 moved away/lost contact, 2 had
Twin Blocks fitted in phase 1 in error, 1
had sore mouth and required treatment in
phase 1
Treatment group: 2 moved away/lost con-
tact, 9 had multiple DNA with no follow-
up records, 4 did not start as eligibility cri-
teria was not met, 5 refused to continue, 1
had poor oral health, 1 removed from study
due to health problems

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 73
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UK (Mixed) 2009 (Continued)

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk Groups appear similar at baseline

Yaqoob 2012

Methods Location: United Kingdom

Number of centres: 1 (Kent and Canterbury Hospital)
Recruitment period: not stated
Funding source: not stated
Trial design: parallel group RCT

Participants Inclusion criteria: children aged 10 to 14 years with Class II Division 1 incisor relationship
(British Standards Institute), overjet greater than 6 mm, molar relationship at least a half
unit Angle Class II, white ethnic origin
Exclusion criteria: previous history of orthodontic therapy or permanent tooth extraction,
no significant or adverse medical history or craniofacial syndrome
Age at baseline: mean Gp A 12.5 years (range 10.5 to 13.5 years), Gp B 12.3 years (range
10.8 to 13.2 years)
Number randomised: 64
Number evaluated: 60

Interventions Gp A: Twin Block appliance with a passive upper labial bow (CTB-LB)
Gp B: Twin Block appliance was constructed with no labial bow (CTB-NLB)
Both appliances to be worn full time and only removed for cleaning or during partici-
pation of child in contact sports

Outcomes (i) Overjet

(ii) Skeletal discrepancy

Notes Duration of intervention: 12 months

Sample size calculation: “Based on previous research and statistical analysis, a minimum
of 52 subjects were required (26 in each group) for the study to have a power of 0.95
to detect a significant difference of 5 degrees in upper incisor retroclination at the 5%
significance level. To compensate for attrition of the sample, 64 subjects were recruited
overall. Power calculations were performed on G*Power 3 (Institute for Experimental
Psychology, Dusseldorf, Germany).”

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “A stratified allocation sequence was gen-
bias) erated using an electronic computer pro-
gram. Patients were stratified according to
age and gender. All patients were placed
into age- (62 mo) and gender-matched

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Yaqoob 2012 (Continued)

pairs. Pairs of patients were matched ac-

cording to age and sex, with one patient
from each pair randomly selected and al-
located to either treatment group (using
[Link]).”

Allocation concealment (selection bias) Low risk Allocation performed using a central web-
site

Blinding of outcome assessment (detection Low risk “Tracings were carried out in a blind man-
bias) ner by one researcher.”
All outcomes

Incomplete outcome data (attrition bias) Low risk 4 dropouts. 2 in CTB-LB and 2 in CTB-
All outcomes NLB
Reasons for dropouts: failed to attend the
follow-up appointment Unlikely to have
introduced bias

Selective reporting (reporting bias) Low risk All variables reported

Other bias Low risk No other sources of bias identified

CI = confidence interval; Gp = group; mm = millimetre; RCT = randomised controlled trial; SD = standard deviation

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Aknin 2000 Comparative study but not randomly allocated to interventions

Aksakalli 2016 Mean age not less than 16 years and does not satisfy inclusion criteria for prominent upper front teeth

Al-Sibaie 2014 Inclusion of adults

Antonarakis 2015 Comparative study but not randomly allocated to interventions

Primary outcome was bite force

Antunes 2013 Not RCT

Ashmore 2002 Not RCT

Aslan 2014 Inclusion of Class II division 2 patients

Baccetti 2009 Not RCT

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Bailleau 2012 Not RCT

Bishara 1995 Not RCT

Booij 2013 Not RCT

Bremen 2015 Not RCT

Burhan 2013 Inclusion of Class II division 2 patients

Chavan 2014 Not RCT

Contacted authors. No response received

Chen 2013 Inclusion of adults

Chen 2015 Not RCT

Contacted authors. No response received

Chintakanon 2000 Not RCT

Chiqueto 2013 Not RCT

Contacted authors. No response received

Collett 2000 Not RCT

Cura 1996 Not RCT

Dahan 1989 Not RCT

Davoody 2011 Abstract only. No subsequent publication identified. Insufficient information to include in review

De Almeida 2002 Not RCT

DeVincenzo 1989 Comparative study but not randomly allocated to interventions

dos Santos-Pinto 2013 Not RCT

Du 2002 Comparative study but not randomly allocated to interventions

El-Dawlatly 2014 Not RCT

Erbas 2014 Not RCT

Erverdi 1995 Not RCT

Contacted authors. No response received

Falck 1989 Not RCT

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Fang 2006 Not RCT

Fernandes 2010 Not RCT

Firouz 1992 Not RCT

Franchi 2013 Not RCT

Franco 2002 Imaging study of effects of orthodontic treatment on TMJ. Not relevant

Freeman 2009 Not RCT

Ghafari 2012 Abstract only. No subsequent publication identified. Insufficient information to include in review

Ghiglione 2000 Abstract only. No subsequent publication identified. Insufficient information to include in review

Gianelly 1983 Not RCT

Gong 2014 Not RCT

Gong 2015 Not RCT

Guner 2003 Not RCT

Hagg 2002 Comparative study but not randomly allocated to interventions

Haj-Younis 2016 Included adults. Average age 22.3 years

Harvold 1971 Not RCT

Hemmatpour 2017 Not an RCT

Hiyama 2002 Not RCT

Ingervall 1991 Comparative study but not randomly allocated to interventions

Iscan 1997 Comparative study but not randomly allocated to interventions

Janson 2003 Not RCT

Jarrell 2001 Abstract only. No subsequent publication found and insufficient information to include in review

Jena 2013 Not RCT

Johansson 2012 Inclusion of Class II division 2 patients

Kalra 1989 Not RCT

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 77
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Kaya 2013 Not RCT

Keski-Nisula 2003 Not RCT

Kumar 1996 Not RCT

Landazuri 2013 Not RCT

Lange 1995 Not RCT

Lee 2013 Not RCT

Li 2010a Not RCT

Li 2010b Not RCT

Lima 2013 Not RCT

Lombardo 2013 Not RCT

Lund 1998 Not RCT

Mai 2014 No information on ANB and overjet

Contacted authors. No response received

Malmgren 1987 Not RCT

Malta 2010 Not RCT

Mariani 2014 Not RCT

Meral 2004 Inclusion criteria - not increased overjet

Miles 2016 No comparison group (no untreated control or another type of orthodontic appliance). Study not primarily
for prominent upper front teeth patients. Outcome of interest not relevant

Muniandy 2000 Not Class II

Nelson 2000 Comparative study but not randomly allocated to interventions

Neves 2014 Not RCT

Op Heij 1989 Not RCT

Ozturk 1994 Comparative study but no randomisation

Pangrazio 1999 Retrospective

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 78
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Pangrazio 2003 Not RCT

Parkin 2001 Not RCT

Patel 2013 Not RCT

Phan 2006 Not RCT

Phelan 2012 Not RCT

Pirttiniemi 2005 Only 20% of participants had Class II malocclusion

Reukers 1998 Included participants with Class II Division 2 malocclusion

Saikoski 2014 Not RCT

Sari 2003 Comparative study but not randomly allocated to interventions

Schaefer 2004 Not RCT

Shannon 2004 Not RCT

Showkatbakhsh 2013 Not RCT

Siara-Olds 2010 Not RCT

Siqueira 2007 Not RCT

Song 2008 Not RCT

Taner 2003 Comparative retrospective study

Thuer 1989 Comparative study but not randomly allocated to interventions

Tumer 1999 Comparative study but not randomly allocated to interventions

Turkkahraman 2016 Not an RCT

Ucem 1998 Comparison of matched groups

Ucuncu 2001 Comparison of matched groups

Uzuner 2014 Not RCT

Wey 2007 Not RCT

Wieslander 1984 Not RCT

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 79
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Witt 1999 Comparison of matched groups

Yang 2006 Inclusion of adults

You 2006 Not RCT

RCT = randomised controlled trial; TMJ = temporomandibular joint

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DATA AND ANALYSES

Comparison 1. Early orthodontic treatment: two-phase versus one-phase treatment

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Outcomes at the end of phase I: 3 Mean Difference (IV, Fixed, 95% CI) Subtotals only
functional versus observation
1.1 Final overjet 3 432 Mean Difference (IV, Fixed, 95% CI) -4.17 [-4.61, -3.73]
1.2 Final ANB 3 419 Mean Difference (IV, Fixed, 95% CI) -0.89 [-1.38, -0.40]
1.3 PAR score 2 349 Mean Difference (IV, Fixed, 95% CI) -10.52 [-12.32, -8.
71]
1.4 Self concept 1 135 Mean Difference (IV, Fixed, 95% CI) -3.63 [-7.66, 0.40]
2 Incidence of new incisal trauma 2 281 Odds Ratio (M-H, Fixed, 95% CI) 0.72 [0.35, 1.49]
during phase I treatment:
functional versus observation
3 Outcomes at the end of phase I: 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only
headgear versus observation
3.1 Final overjet 2 278 Mean Difference (IV, Fixed, 95% CI) -1.07 [-1.63, -0.51]
3.2 Final ANB 2 277 Mean Difference (IV, Fixed, 95% CI) -0.72 [-1.18, -0.27]
4 Incidence of new incisal trauma 2 285 Odds Ratio (M-H, Fixed, 95% CI) 0.76 [0.37, 1.54]
during phase I treatment:
headgear versus observation
5 Outcomes at the end of phase 3 Mean Difference (IV, Fixed, 95% CI) Subtotals only
II: functional (2-phase) versus
adolescent (1-phase) treatment
5.1 Final overjet 3 343 Mean Difference (IV, Fixed, 95% CI) 0.21 [-0.10, 0.51]
5.2 Final ANB 3 347 Mean Difference (IV, Fixed, 95% CI) -0.02 [-0.47, 0.43]
5.3 PAR score 3 360 Mean Difference (IV, Fixed, 95% CI) 0.62 [-0.66, 1.91]
5.4 Self concept 1 132 Mean Difference (IV, Fixed, 95% CI) -0.83 [-3.97, 2.31]
6 Incidence of new incisal 3 332 Odds Ratio (M-H, Fixed, 95% CI) 0.56 [0.33, 0.95]
trauma by the end of phase II
treatment: functional (2-phase)
versus adolescent (1-phase)
treatment
7 Outcomes at the end of phase 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only
II: headgear (2-phase) versus
adolescent (1-phase) treatment
7.1 Final overjet 2 238 Mean Difference (IV, Fixed, 95% CI) -0.22 [-0.56, 0.12]
7.2 Final ANB 2 231 Mean Difference (IV, Fixed, 95% CI) -0.27 [-0.80, 0.26]
7.3 PAR score 2 177 Mean Difference (IV, Fixed, 95% CI) -1.55 [-3.70, 0.60]
8 Incidence of new incisal 2 237 Odds Ratio (M-H, Fixed, 95% CI) 0.45 [0.25, 0.80]
trauma by the end of phase II
treatment: headgear (2-phase)
versus adolescent (1-phase)
treatment

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Comparison 2. Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional)

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Outcomes at the end of phase I: 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only
headgear versus functional
1.1 Final overjet 2 271 Mean Difference (IV, Fixed, 95% CI) 0.75 [0.21, 1.29]
1.2 Final ANB 2 271 Mean Difference (IV, Fixed, 95% CI) -0.04 [-0.49, 0.41]
2 Incidence of new incisal trauma 2 282 Odds Ratio (M-H, Fixed, 95% CI) 1.02 [0.48, 2.17]
during phase I treatment:
headgear versus functional
3 Outcomes at the end of phase II: 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only
headgear versus functional
3.1 Final overjet 2 225 Mean Difference (IV, Fixed, 95% CI) -0.21 [-0.57, 0.15]
3.2 Final ANB 2 222 Mean Difference (IV, Fixed, 95% CI) -0.17 [-0.67, 0.34]
3.3 PAR score 2 224 Mean Difference (IV, Fixed, 95% CI) -0.81 [-2.21, 0.58]
4 Incidence of new incisal 2 226 Odds Ratio (M-H, Fixed, 95% CI) 0.78 [0.42, 1.47]
trauma by the end of phase
II treatment: headgear versus
functional appliance

Comparison 3. Late orthodontic treatment: functional versus no treatment

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Final overjet 5 Mean Difference (IV, Fixed, 95% CI) Subtotals only
1.1 Fixed functional 2 61 Mean Difference (IV, Fixed, 95% CI) -5.46 [-6.63, -4.28]
1.2 Removable functional 3 122 Mean Difference (IV, Fixed, 95% CI) -4.62 [-5.33, -3.92]
2 Final ANB 5 Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.1 Fixed functional 3 89 Mean Difference (IV, Fixed, 95% CI) -0.53 [-1.27, 0.22]
2.2 Removable functional 2 99 Mean Difference (IV, Fixed, 95% CI) -2.37 [-3.01, -1.74]

Comparison 4. Late orthodontic treatment: different types of appliances used for late treatment

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Twin Block versus other 6 Mean Difference (IV, Random, 95% CI) Subtotals only
functional appliances
(R-appliance, Bionator,
Bite-Jumping appliance,
Dynamax and Herbst)
1.1 Final overjet 4 259 Mean Difference (IV, Random, 95% CI) 0.08 [-0.60, 0.76]
1.2 Final ANB 6 320 Mean Difference (IV, Random, 95% CI) -0.56 [-0.96, -0.16]
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2 Twin Block conventional versus 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only
other Twin Block modifications
2.1 Final overjet 2 196 Mean Difference (IV, Fixed, 95% CI) -0.23 [-0.67, 0.22]
3 Functional (Activator) versus 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only
prefabricated functional
myobrace appliance (PFA)
3.1 Final overjet 1 97 Mean Difference (IV, Fixed, 95% CI) -0.60 [-1.63, 0.43]
4 Functional (Activator) versus 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only
fixed functional (FORSUS
FRD EZ)
4.1 Final overjet 1 24 Mean Difference (IV, Fixed, 95% CI) 2.19 [0.58, 3.80]
4.2 Final ANB 1 24 Mean Difference (IV, Fixed, 95% CI) -1.74 [-3.28, -0.20]
5 Fixed functional (FORSUS 2 Mean Difference (IV, Fixed, 95% CI) Subtotals only
FRD) versus fixed functional
with mini-implants (FMI)
5.1 Final overjet 1 29 Mean Difference (IV, Fixed, 95% CI) -0.36 [-1.07, 0.35]
5.2 Final ANB 2 60 Mean Difference (IV, Fixed, 95% CI) 0.22 [-0.86, 1.30]
6 Fixed functional (FORSUS 1 32 Odds Ratio (M-H, Fixed, 95% CI) 0.18 [0.01, 3.97]
FRD) versus fixed functional
with mini-implants (FMI) -
patient satisfaction with results
7 R-appliance versus AIBP 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only
7.1 Final ANB 1 50 Mean Difference (IV, Fixed, 95% CI) -0.30 [-0.99, 0.39]
8 Removable functional appliance 3 Mean Difference (IV, Fixed, 95% CI) Subtotals only
versus fixed functional
appliance
8.1 Final overjet 2 154 Mean Difference (IV, Fixed, 95% CI) 0.74 [0.15, 1.33]
8.2 Final ANB 3 185 Mean Difference (IV, Fixed, 95% CI) -1.04 [-1.60, -0.49]
9 FORSUS versus intermaxillary 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only
elastics
9.1 Final overjet 1 28 Mean Difference (IV, Fixed, 95% CI) 0.28 [-0.35, 0.91]
9.2 Final ANB 1 28 Mean Difference (IV, Fixed, 95% CI) -0.90 [-1.96, 0.16]
10 FMA stepwise (SWG) versus 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only
FMA single step (SSG)
10.1 Final overjet 1 34 Mean Difference (IV, Fixed, 95% CI) 0.23 [-0.26, 0.72]
10.2 Final ANB 1 34 Mean Difference (IV, Fixed, 95% CI) -0.69 [-1.19, -0.19]
11 Harvold Activator versus 1 25 Mean Difference (IV, Fixed, 95% CI) -2.93 [-5.37, -0.49]
Frankel function regulator
11.1 Overjet change 1 25 Mean Difference (IV, Fixed, 95% CI) -2.93 [-5.37, -0.49]

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.1. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
1 Outcomes at the end of phase I: functional versus observation.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 1 Outcomes at the end of phase I: functional versus observation

Mean Mean
Study or subgroup Functional Observation Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Florida 1998 85 3.88 (1.9) 79 5.42 (2.67) 38.3 % -1.54 [ -2.25, -0.83 ]

North Carolina 2004 41 5.38 (2.67) 54 8.94 (1.84) 21.5 % -3.56 [ -4.51, -2.61 ]

UK (Mixed) 2009 89 3.7 (2.27) 84 10.7 (2.4) 40.2 % -7.00 [ -7.70, -6.30 ]

Subtotal (95% CI) 215 217 100.0 % -4.17 [ -4.61, -3.73 ]

Heterogeneity: Chi2 = 117.02, df = 2 (P<0.00001); I2 =98%
Test for overall effect: Z = 18.49 (P < 0.00001)
2 Final ANB
Florida 1998 85 3.96 (1.95) 78 4.49 (2.19) 59.0 % -0.53 [ -1.17, 0.11 ]

North Carolina 2004 41 4.82 (2.08) 54 5.77 (2.08) 33.7 % -0.95 [ -1.79, -0.11 ]

UK (Mixed) 2009 87 3.85 (1.8) 74 7.35 (7.8) 7.3 % -3.50 [ -5.32, -1.68 ]

Subtotal (95% CI) 213 206 100.0 % -0.89 [ -1.38, -0.40 ]

Heterogeneity: Chi2 = 9.17, df = 2 (P = 0.01); I2 =78%
Test for overall effect: Z = 3.55 (P = 0.00039)
3 PAR score
Florida 1998 94 17.7 (7.4) 84 22 (9.2) 53.5 % -4.30 [ -6.77, -1.83 ]

UK (Mixed) 2009 87 18.04 (7.3) 84 35.7 (10.1) 46.5 % -17.66 [ -20.31, -15.01 ]

Subtotal (95% CI) 181 168 100.0 % -10.52 [ -12.32, -8.71 ]

Heterogeneity: Chi2 = 52.23, df = 1 (P<0.00001); I2 =98%
Test for overall effect: Z = 11.41 (P < 0.00001)
4 Self concept
UK (Mixed) 2009 65 -63.32 (10.22) 70 -59.69 (13.55) 100.0 % -3.63 [ -7.66, 0.40 ]

Subtotal (95% CI) 65 70 100.0 % -3.63 [ -7.66, 0.40 ]

Heterogeneity: not applicable
Test for overall effect: Z = 1.77 (P = 0.078)

-20 -10 0 10 20
Favours functional Favours observation

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 84
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.2. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
2 Incidence of new incisal trauma during phase I treatment: functional versus observation.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 2 Incidence of new incisal trauma during phase I treatment: functional versus observation

Study or subgroup Functional appliance Observation Odds Ratio Weight Odds Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Florida 1998 12/87 11/81 55.7 % 1.02 [ 0.42, 2.46 ]

North Carolina 2004 3/52 9/61 44.3 % 0.35 [ 0.09, 1.38 ]

Total (95% CI) 139 142 100.0 % 0.72 [ 0.35, 1.49 ]

Total events: 15 (Functional appliance), 20 (Observation)
Heterogeneity: Chi2 = 1.64, df = 1 (P = 0.20); I2 =39%
Test for overall effect: Z = 0.88 (P = 0.38)
Test for subgroup differences: Not applicable

0.1 0.2 0.5 1 2 5 10

Favours functional Favours observation

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 85
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.3. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
3 Outcomes at the end of phase I: headgear versus observation.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 3 Outcomes at the end of phase I: headgear versus observation

Mean Mean
Study or subgroup Headgear Observation Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Florida 1998 95 3.99 (2.33) 79 5 (2.67) 55.8 % -1.01 [ -1.76, -0.26 ]

North Carolina 2004 50 7.8 (2.48) 54 8.94 (1.84) 44.2 % -1.14 [ -1.98, -0.30 ]

Subtotal (95% CI) 145 133 100.0 % -1.07 [ -1.63, -0.51 ]

Heterogeneity: Chi2 = 0.05, df = 1 (P = 0.82); I2 =0.0%
Test for overall effect: Z = 3.72 (P = 0.00020)
2 Final ANB
Florida 1998 95 3.89 (1.85) 78 4.49 (2.19) 55.0 % -0.60 [ -1.21, 0.01 ]

North Carolina 2004 50 4.83 (1.5) 54 5.7 (2) 45.0 % -0.87 [ -1.55, -0.19 ]

Subtotal (95% CI) 145 132 100.0 % -0.72 [ -1.18, -0.27 ]

Heterogeneity: Chi2 = 0.34, df = 1 (P = 0.56); I2 =0.0%
Test for overall effect: Z = 3.12 (P = 0.0018)

-2 -1 0 1 2
Favours headgear Favours observation

Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents (Review) 86
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.4. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
4 Incidence of new incisal trauma during phase I treatment: headgear versus observation.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 4 Incidence of new incisal trauma during phase I treatment: headgear versus observation

Study or subgroup Headgear Observation Odds Ratio Weight Odds Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Florida 1998 12/93 11/81 57.9 % 0.94 [ 0.39, 2.27 ]

North Carolina 2004 4/50 9/61 42.1 % 0.50 [ 0.14, 1.74 ]

Total (95% CI) 143 142 100.0 % 0.76 [ 0.37, 1.54 ]

Total events: 16 (Headgear), 20 (Observation)
Heterogeneity: Chi2 = 0.66, df = 1 (P = 0.42); I2 =0.0%
Test for overall effect: Z = 0.77 (P = 0.44)
Test for subgroup differences: Not applicable

0.1 0.2 0.5 1 2 5 10

Favours headgear Favours observation

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 Analysis 1.5. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
5 Outcomes at the end of phase II: functional (2-phase) versus adolescent (1-phase) treatment.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 5 Outcomes at the end of phase II: functional (2-phase) versus adolescent (1-phase) treatment

One phase
(adolescent Mean Mean
Study or subgroup Two phase (early tx) tx) Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Florida 1998 67 2.6 (1.12) 68 2.49 (1.08) 65.9 % 0.11 [ -0.26, 0.48 ]

North Carolina 2004 39 3.72 (2.04) 51 3.99 (1.75) 14.2 % -0.27 [ -1.07, 0.53 ]

UK (Mixed) 2009 56 4.3 (2.15) 62 3.44 (1.49) 20.0 % 0.86 [ 0.19, 1.53 ]

Subtotal (95% CI) 162 181 100.0 % 0.21 [ -0.10, 0.51 ]

Heterogeneity: Chi2 = 5.23, df = 2 (P = 0.07); I2 =62%
Test for overall effect: Z = 1.34 (P = 0.18)
2 Final ANB
Florida 1998 65 3.7 (1.9) 62 3.49 (2.35) 36.2 % 0.21 [ -0.54, 0.96 ]

North Carolina 2004 39 3.72 (2.12) 51 4.36 (2.06) 26.4 % -0.64 [ -1.51, 0.23 ]

UK (Mixed) 2009 62 4 (1.99) 68 3.81 (2.28) 37.3 % 0.19 [ -0.54, 0.92 ]

Subtotal (95% CI) 166 181 100.0 % -0.02 [ -0.47, 0.43 ]

Heterogeneity: Chi2 = 2.62, df = 2 (P = 0.27); I2 =24%
Test for overall effect: Z = 0.10 (P = 0.92)
3 PAR score
Florida 1998 66 6 (5) 70 6 (4.4) 65.6 % 0.0 [ -1.59, 1.59 ]

North Carolina 2004 39 8.4 (7.7) 51 9.3 (8.1) 15.3 % -0.90 [ -4.18, 2.38 ]

UK (Mixed) 2009 64 10.42 (10.42) 70 6.44 (6.23) 19.1 % 3.98 [ 1.04, 6.92 ]

Subtotal (95% CI) 169 191 100.0 % 0.62 [ -0.66, 1.91 ]

Heterogeneity: Chi2 = 6.43, df = 2 (P = 0.04); I2 =69%
Test for overall effect: Z = 0.95 (P = 0.34)
4 Self concept
UK (Mixed) 2009 62 -68.87 (8.32) 70 -68.04 (10.09) 100.0 % -0.83 [ -3.97, 2.31 ]

Subtotal (95% CI) 62 70 100.0 % -0.83 [ -3.97, 2.31 ]

Heterogeneity: not applicable
Test for overall effect: Z = 0.52 (P = 0.60)

-10 -5 0 5 10
Favours two phase (early) Favours one phase (adol)

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 Analysis 1.6. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
6 Incidence of new incisal trauma by the end of phase II treatment: functional (2-phase) versus adolescent (1-
phase) treatment.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 6 Incidence of new incisal trauma by the end of phase II treatment: functional (2-phase) versus adolescent (1-phase) treatment

Adolescent
Study or subgroup Functional treatment Odds Ratio Weight Odds Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Florida 1998 19/67 23/69 42.6 % 0.79 [ 0.38, 1.64 ]

North Carolina 2004 8/42 21/51 40.3 % 0.34 [ 0.13, 0.87 ]

UK (Mixed) 2009 4/52 7/51 17.1 % 0.52 [ 0.14, 1.91 ]

Total (95% CI) 161 171 100.0 % 0.56 [ 0.33, 0.95 ]

Total events: 31 (Functional), 51 (Adolescent treatment)
Heterogeneity: Chi2 = 1.98, df = 2 (P = 0.37); I2 =0.0%
Test for overall effect: Z = 2.16 (P = 0.031)
Test for subgroup differences: Not applicable

0.2 0.5 1 2 5
Favours functional Favours adolescent

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 Analysis 1.7. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
7 Outcomes at the end of phase II: headgear (2-phase) versus adolescent (1-phase) treatment.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 7 Outcomes at the end of phase II: headgear (2-phase) versus adolescent (1-phase) treatment

Headgear
(two Adolescent Mean Mean
Study or subgroup phase) (one phase) Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Florida 1998 72 2.4 (1.38) 68 2.49 (1.08) 68.6 % -0.09 [ -0.50, 0.32 ]

North Carolina 2004 47 3.48 (1.29) 51 3.99 (1.75) 31.4 % -0.51 [ -1.12, 0.10 ]

Subtotal (95% CI) 119 119 100.0 % -0.22 [ -0.56, 0.12 ]

Heterogeneity: Chi2 = 1.27, df = 1 (P = 0.26); I2 =21%
Test for overall effect: Z = 1.28 (P = 0.20)
2 Final ANB
Florida 1998 71 3.3 (1.8) 62 3.49 (2.35) 54.4 % -0.19 [ -0.91, 0.53 ]

North Carolina 2004 47 4 (1.91) 51 4.36 (2.06) 45.6 % -0.36 [ -1.15, 0.43 ]

Subtotal (95% CI) 118 113 100.0 % -0.27 [ -0.80, 0.26 ]

Heterogeneity: Chi2 = 0.10, df = 1 (P = 0.75); I2 =0.0%
Test for overall effect: Z = 0.99 (P = 0.32)
3 PAR score
Florida 1998 72 5.3 (4.5) 7 6 (4.4) 39.4 % -0.70 [ -4.12, 2.72 ]

North Carolina 2004 47 7.2 (5.7) 51 9.3 (8.1) 60.6 % -2.10 [ -4.86, 0.66 ]

Subtotal (95% CI) 119 58 100.0 % -1.55 [ -3.70, 0.60 ]

Heterogeneity: Chi2 = 0.39, df = 1 (P = 0.53); I2 =0.0%
Test for overall effect: Z = 1.41 (P = 0.16)

-4 -2 0 2 4
Favours headgear (2 phase Favours adolesc (1 phase)

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 Analysis 1.8. Comparison 1 Early orthodontic treatment: two-phase versus one-phase treatment, Outcome
8 Incidence of new incisal trauma by the end of phase II treatment: headgear (2-phase) versus adolescent (1-
phase) treatment.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 1 Early orthodontic treatment: two-phase versus one-phase treatment

Outcome: 8 Incidence of new incisal trauma by the end of phase II treatment: headgear (2-phase) versus adolescent (1-phase) treatment

Adolescent
Study or subgroup Headgear treatment Odds Ratio Weight Odds Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Florida 1998 16/71 23/69 52.3 % 0.58 [ 0.28, 1.23 ]

North Carolina 2004 8/46 21/51 47.7 % 0.30 [ 0.12, 0.77 ]

Total (95% CI) 117 120 100.0 % 0.45 [ 0.25, 0.80 ]

Total events: 24 (Headgear), 44 (Adolescent treatment)
Heterogeneity: Chi2 = 1.15, df = 1 (P = 0.28); I2 =13%
Test for overall effect: Z = 2.71 (P = 0.0068)
Test for subgroup differences: Not applicable

0.1 0.2 0.5 1 2 5 10

Favours headgear Favours adolescent

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 Analysis 2.1. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus
appliance 2 (functional), Outcome 1 Outcomes at the end of phase I: headgear versus functional.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional)

Outcome: 1 Outcomes at the end of phase I: headgear versus functional

Mean Mean
Study or subgroup Headgear Functional Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Florida 1998 95 3.99 (2.33) 85 3.8 (1.9) 74.9 % 0.19 [ -0.43, 0.81 ]

North Carolina 2004 50 7.8 (2.48) 41 5.38 (2.67) 25.1 % 2.42 [ 1.35, 3.49 ]

Subtotal (95% CI) 145 126 100.0 % 0.75 [ 0.21, 1.29 ]

Heterogeneity: Chi2 = 12.54, df = 1 (P = 0.00040); I2 =92%
Test for overall effect: Z = 2.75 (P = 0.0060)
2 Final ANB
Florida 1998 95 3.89 (1.85) 85 3.96 (1.95) 65.1 % -0.07 [ -0.63, 0.49 ]

North Carolina 2004 50 4.83 (1.5) 41 4.82 (2.08) 34.9 % 0.01 [ -0.75, 0.77 ]

Subtotal (95% CI) 145 126 100.0 % -0.04 [ -0.49, 0.41 ]

Heterogeneity: Chi2 = 0.03, df = 1 (P = 0.87); I2 =0.0%
Test for overall effect: Z = 0.18 (P = 0.85)

-4 -2 0 2 4
Favours headgear Favours functional

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 Analysis 2.2. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus
appliance 2 (functional), Outcome 2 Incidence of new incisal trauma during phase I treatment: headgear
versus functional.
Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional)

Outcome: 2 Incidence of new incisal trauma during phase I treatment: headgear versus functional

Study or subgroup Headgear Functional Odds Ratio Weight Odds Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Florida 1998 12/93 12/87 80.0 % 0.93 [ 0.39, 2.19 ]

North Carolina 2004 4/50 3/52 20.0 % 1.42 [ 0.30, 6.69 ]

Total (95% CI) 143 139 100.0 % 1.02 [ 0.48, 2.17 ]

Total events: 16 (Headgear), 15 (Functional)
Heterogeneity: Chi2 = 0.22, df = 1 (P = 0.64); I2 =0.0%
Test for overall effect: Z = 0.06 (P = 0.95)
Test for subgroup differences: Not applicable

0.1 0.2 0.5 1 2 5 10

Favours headgear Favours functional

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 Analysis 2.3. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus
appliance 2 (functional), Outcome 3 Outcomes at the end of phase II: headgear versus functional.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional)

Outcome: 3 Outcomes at the end of phase II: headgear versus functional

Mean Mean
Study or subgroup Headgear Functional Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Florida 1998 72 2.4 (1.38) 67 2.6 (1.12) 75.9 % -0.20 [ -0.62, 0.22 ]

North Carolina 2004 47 3.48 (1.29) 39 3.72 (2.04) 24.1 % -0.24 [ -0.98, 0.50 ]

Subtotal (95% CI) 119 106 100.0 % -0.21 [ -0.57, 0.15 ]

Heterogeneity: Chi2 = 0.01, df = 1 (P = 0.93); I2 =0.0%
Test for overall effect: Z = 1.13 (P = 0.26)
2 Final ANB
Florida 1998 71 3.3 (1.8) 65 3.7 (1.9) 65.5 % -0.40 [ -1.02, 0.22 ]

North Carolina 2004 47 4 (1.9) 39 3.72 (2.12) 34.5 % 0.28 [ -0.58, 1.14 ]

Subtotal (95% CI) 118 104 100.0 % -0.17 [ -0.67, 0.34 ]

Heterogeneity: Chi2 = 1.58, df = 1 (P = 0.21); I2 =37%
Test for overall effect: Z = 0.64 (P = 0.52)
3 PAR score
Florida 1998 72 5.3 (4.5) 66 6 (5) 77.0 % -0.70 [ -2.29, 0.89 ]

North Carolina 2004 47 7.2 (5.7) 39 8.4 (7.7) 23.0 % -1.20 [ -4.11, 1.71 ]

Subtotal (95% CI) 119 105 100.0 % -0.81 [ -2.21, 0.58 ]

Heterogeneity: Chi2 = 0.09, df = 1 (P = 0.77); I2 =0.0%
Test for overall effect: Z = 1.14 (P = 0.25)

-4 -2 0 2 4
Favours headgear Favours functional

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 Analysis 2.4. Comparison 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus
appliance 2 (functional), Outcome 4 Incidence of new incisal trauma by the end of phase II treatment:
headgear versus functional appliance.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 2 Early orthodontic treatment: two-phase appliance 1 (headgear) versus appliance 2 (functional)

Outcome: 4 Incidence of new incisal trauma by the end of phase II treatment: headgear versus functional appliance

Study or subgroup Headgear Functional Odds Ratio Weight Odds Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Florida 1998 16/71 19/67 68.7 % 0.73 [ 0.34, 1.59 ]

North Carolina 2004 8/46 8/42 31.3 % 0.89 [ 0.30, 2.64 ]

Total (95% CI) 117 109 100.0 % 0.78 [ 0.42, 1.47 ]

Total events: 24 (Headgear), 27 (Functional)
Heterogeneity: Chi2 = 0.08, df = 1 (P = 0.77); I2 =0.0%
Test for overall effect: Z = 0.76 (P = 0.45)
Test for subgroup differences: Not applicable

0.1 0.2 0.5 1 2 5 10

Favours headgear Favours functional

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 Analysis 3.1. Comparison 3 Late orthodontic treatment: functional versus no treatment, Outcome 1 Final
overjet.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 3 Late orthodontic treatment: functional versus no treatment

Outcome: 1 Final overjet

Mean Mean
Study or subgroup Favours functional No treatment Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Fixed functional
Alali 2014 21 4.42 (1.5) 17 7.47 (3.02) 55.9 % -3.05 [ -4.62, -1.48 ]

Eissa 2017 14 2.06 (1.17) 9 10.56 (2.54) 44.1 % -8.50 [ -10.27, -6.73 ]

Subtotal (95% CI) 35 26 100.0 % -5.46 [ -6.63, -4.28 ]

Heterogeneity: Chi2 = 20.37, df = 1 (P<0.00001); I2 =95%
Test for overall effect: Z = 9.10 (P < 0.00001)
2 Removable functional
Cura 1997 27 4.68 (1.75) 20 9.9 (2.53) 29.7 % -5.22 [ -6.51, -3.93 ]

Martina 2013 23 3.6 (1.3) 23 7.8 (1.8) 60.1 % -4.20 [ -5.11, -3.29 ]

New Zealand 2000 12 -5.17 (3.75) 17 0.21 (1.21) 10.2 % -5.38 [ -7.58, -3.18 ]

Subtotal (95% CI) 62 60 100.0 % -4.62 [ -5.33, -3.92 ]

Heterogeneity: Chi2 = 2.11, df = 2 (P = 0.35); I2 =5%
Test for overall effect: Z = 12.89 (P < 0.00001)

-10 -5 0 5 10
Favours functional Favours no treatment

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 Analysis 3.2. Comparison 3 Late orthodontic treatment: functional versus no treatment, Outcome 2 Final
ANB.
Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 3 Late orthodontic treatment: functional versus no treatment

Outcome: 2 Final ANB

Mean Mean
Study or subgroup Functional No treatment Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Fixed functional
Alali 2014 21 5.14 (1.48) 17 6.3 (1.95) 43.7 % -1.16 [ -2.28, -0.04 ]

Eissa 2017 14 6.72 (3.12) 9 7.92 (1.58) 14.7 % -1.20 [ -3.13, 0.73 ]

Elkordy 2016 16 7 (2.01) 12 6.62 (1.05) 41.6 % 0.38 [ -0.77, 1.53 ]

Subtotal (95% CI) 51 38 100.0 % -0.53 [ -1.27, 0.22 ]

Heterogeneity: Chi2 = 4.08, df = 2 (P = 0.13); I2 =51%
Test for overall effect: Z = 1.39 (P = 0.17)
2 Removable functional
Cura 1997 27 4.85 (2.21) 20 6.5 (2) 27.7 % -1.65 [ -2.86, -0.44 ]

Mao 1997 26 3.88 (1.51) 26 6.53 (1.23) 72.3 % -2.65 [ -3.40, -1.90 ]

Subtotal (95% CI) 53 46 100.0 % -2.37 [ -3.01, -1.74 ]

Heterogeneity: Chi2 = 1.90, df = 1 (P = 0.17); I2 =47%
Test for overall effect: Z = 7.31 (P < 0.00001)

-4 -2 0 2 4
Favours functional Favours no treatment

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 Analysis 4.1. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 1 Twin Block versus other functional appliances (R-appliance, Bionator, Bite-Jumping
appliance, Dynamax and Herbst).

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 1 Twin Block versus other functional appliances (R-appliance, Bionator, Bite-Jumping appliance, Dynamax and Herbst)

Other
functional Mean Mean
Study or subgroup Twin Block applianc Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

1 Final overjet
Burhan 2015 20 3.12 (1.56) 20 2.68 (1.74) 23.0 % 0.44 [ -0.58, 1.46 ]

Jamilian 2011 25 2.8 (1.3) 30 3.5 (1.5) 30.7 % -0.70 [ -1.44, 0.04 ]

London 1998 16 4.5 (2.8) 18 4.4 (2.1) 12.2 % 0.10 [ -1.58, 1.78 ]

UK (11-14) 2003 63 4.05 (2.3) 67 3.53 (1.14) 34.1 % 0.52 [ -0.11, 1.15 ]

Subtotal (95% CI) 124 135 100.0 % 0.08 [ -0.60, 0.76 ]

Heterogeneity: Tau2 = 0.25; Chi2 = 6.61, df = 3 (P = 0.09); I2 =55%
Test for overall effect: Z = 0.22 (P = 0.83)
2 Final ANB
Baysal 2014 20 3.17 (1.68) 20 4.4 (1.72) 14.2 % -1.23 [ -2.28, -0.18 ]

Burhan 2015 20 3.73 (1.37) 20 3.63 (1.2) 24.3 % 0.10 [ -0.70, 0.90 ]

Jamilian 2011 25 4.2 (2.2) 30 4.7 (1.6) 14.7 % -0.50 [ -1.54, 0.54 ]

Jin 2015 15 3.65 (2.23) 15 4.54 (1.32) 9.2 % -0.89 [ -2.20, 0.42 ]

London 1998 16 4.8 (1.8) 18 5 (2.4) 7.9 % -0.20 [ -1.62, 1.22 ]

UK (11-14) 2003 52 3.8 (2) 69 4.6 (2) 29.7 % -0.80 [ -1.52, -0.08 ]

Subtotal (95% CI) 148 172 100.0 % -0.56 [ -0.96, -0.16 ]

Heterogeneity: Tau2 = 0.01; Chi2 = 5.11, df = 5 (P = 0.40); I2 =2%
Test for overall effect: Z = 2.73 (P = 0.0063)

-4 -2 0 2 4
Favours Twin Block Favours other functional

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 Analysis 4.2. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 2 Twin Block conventional versus other Twin Block modifications.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 2 Twin Block conventional versus other Twin Block modifications

Twin Block Twin Block

conven- modifica- Mean Mean
Study or subgroup tional tions Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Banks 2004 76 1.23 (2.013) 60 1.77 (1.471) 57.6 % -0.54 [ -1.13, 0.05 ]

Yaqoob 2012 30 2.2 (1.4) 30 2 (1.3) 42.4 % 0.20 [ -0.48, 0.88 ]

Subtotal (95% CI) 106 90 100.0 % -0.23 [ -0.67, 0.22 ]

Heterogeneity: Chi2 = 2.59, df = 1 (P = 0.11); I2 =61%
Test for overall effect: Z = 1.00 (P = 0.32)

-4 -2 0 2 4
Favours TB conventional Favours TB modifications

Analysis 4.3. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 3 Functional (Activator) versus prefabricated functional myobrace appliance (PFA).

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 3 Functional (Activator) versus prefabricated functional myobrace appliance (PFA)

Prefabricated Mean Mean

Study or subgroup Andresen Appliance functional Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet

Cirgi 2016 40 5.6 (2.66) 57 6.2 (2.39) 100.0 % -0.60 [ -1.63, 0.43 ]

Subtotal (95% CI) 40 57 100.0 % -0.60 [ -1.63, 0.43 ]

Heterogeneity: not applicable
Test for overall effect: Z = 1.14 (P = 0.25)

-4 -2 0 2 4
Andresen Appliance Prefabricated functional

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 Analysis 4.4. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 4 Functional (Activator) versus fixed functional (FORSUS FRD EZ).

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 4 Functional (Activator) versus fixed functional (FORSUS FRD EZ)

fixed functional
(FORSUS FRD Mean Mean
Study or subgroup Functional (Activator) EZ) Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet

Bilgi 2011 12 3.14 (0.97) 12 0.95 (2.68) 100.0 % 2.19 [ 0.58, 3.80 ]

Subtotal (95% CI) 12 12 100.0 % 2.19 [ 0.58, 3.80 ]

Heterogeneity: not applicable
Test for overall effect: Z = 2.66 (P = 0.0078)
2 Final ANB

Bilgi 2011 12 4.14 (1.93) 12 5.88 (1.93) 100.0 % -1.74 [ -3.28, -0.20 ]

Subtotal (95% CI) 12 12 100.0 % -1.74 [ -3.28, -0.20 ]

Heterogeneity: not applicable
Test for overall effect: Z = 2.21 (P = 0.027)

-4 -2 0 2 4
Favours Activator Favours FORSUS

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 Analysis 4.5. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 5 Fixed functional (FORSUS FRD) versus fixed functional with mini-implants (FMI).

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 5 Fixed functional (FORSUS FRD) versus fixed functional with mini-implants (FMI)

Mean Mean
Study or subgroup FFRD FMI Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Eissa 2017 14 2.06 (1.17) 15 2.42 (0.7) 100.0 % -0.36 [ -1.07, 0.35 ]

Subtotal (95% CI) 14 15 100.0 % -0.36 [ -1.07, 0.35 ]

Heterogeneity: not applicable
Test for overall effect: Z = 1.00 (P = 0.32)
2 Final ANB
Eissa 2017 14 6.72 (3.12) 15 7.24 (1.49) 35.8 % -0.52 [ -2.32, 1.28 ]

Elkordy 2016 16 7 (2.01) 15 6.37 (1.81) 64.2 % 0.63 [ -0.71, 1.97 ]

Subtotal (95% CI) 30 30 100.0 % 0.22 [ -0.86, 1.30 ]

Heterogeneity: Chi2 = 1.01, df = 1 (P = 0.32); I2 =1%
Test for overall effect: Z = 0.40 (P = 0.69)

-4 -2 0 2 4
Favours Forsus Favours Forsus + mi

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 Analysis 4.6. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 6 Fixed functional (FORSUS FRD) versus fixed functional with mini-implants (FMI) -
patient satisfaction with results.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 6 Fixed functional (FORSUS FRD) versus fixed functional with mini-implants (FMI) - patient satisfaction with results

Study or subgroup Forsus FRD FMI Odds Ratio Weight Odds Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Elkordy 2016 14/16 16/16 100.0 % 0.18 [ 0.01, 3.97 ]

Total (95% CI) 16 16 100.0 % 0.18 [ 0.01, 3.97 ]

Total events: 14 (Forsus FRD), 16 (FMI)
Heterogeneity: not applicable
Test for overall effect: Z = 1.09 (P = 0.27)
Test for subgroup differences: Not applicable

0.01 0.1 1 10 100

Favours Forsus FRD Favours FMI

Analysis 4.7. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 7 R-appliance versus AIBP.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 7 R-appliance versus AIBP

Mean Mean
Study or subgroup R-appliance AIBP Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final ANB
Showkatbakhsh 2011 25 4.2 (1.3) 25 4.5 (1.2) 100.0 % -0.30 [ -0.99, 0.39 ]

Subtotal (95% CI) 25 25 100.0 % -0.30 [ -0.99, 0.39 ]

Heterogeneity: not applicable
Test for overall effect: Z = 0.85 (P = 0.40)

-4 -2 0 2 4
Favours R-appliance Favours AIBP

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 Analysis 4.8. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 8 Removable functional appliance versus fixed functional appliance.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 8 Removable functional appliance versus fixed functional appliance

Functional
(remov- Mean Mean
Study or subgroup able) Functional (fixed) Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet

Bilgi 2011 12 3.14 (0.97) 12 0.95 (2.68) 13.2 % 2.19 [ 0.58, 3.80 ]

UK (11-14) 2003 63 4.05 (2.3) 67 3.53 (1.14) 86.8 % 0.52 [ -0.11, 1.15 ]

Subtotal (95% CI) 75 79 100.0 % 0.74 [ 0.15, 1.33 ]

Heterogeneity: Chi2 = 3.57, df = 1 (P = 0.06); I2 =72%
Test for overall effect: Z = 2.48 (P = 0.013)
2 Final ANB
Baysal 2014 20 3.17 (1.68) 20 4.4 (1.72) 27.7 % -1.23 [ -2.28, -0.18 ]

Bilgi 2011 12 4.14 (1.93) 12 5.88 (1.93) 12.9 % -1.74 [ -3.28, -0.20 ]

UK (11-14) 2003 52 3.8 (2) 69 4.6 (2) 59.4 % -0.80 [ -1.52, -0.08 ]

Subtotal (95% CI) 84 101 100.0 % -1.04 [ -1.60, -0.49 ]

Heterogeneity: Chi2 = 1.34, df = 2 (P = 0.51); I2 =0.0%
Test for overall effect: Z = 3.68 (P = 0.00024)

-4 -2 0 2 4
Favours removable Favours fixed

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 Analysis 4.9. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 9 FORSUS versus intermaxillary elastics.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 9 FORSUS versus intermaxillary elastics

Intermaxillary Mean Mean

Study or subgroup FORSUS elastics Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Aras 2017b 14 2.36 (0.83) 14 2.08 (0.88) 100.0 % 0.28 [ -0.35, 0.91 ]

Subtotal (95% CI) 14 14 100.0 % 0.28 [ -0.35, 0.91 ]

Heterogeneity: not applicable
Test for overall effect: Z = 0.87 (P = 0.39)
2 Final ANB
Aras 2017b 14 3.32 (1.38) 14 4.22 (1.49) 100.0 % -0.90 [ -1.96, 0.16 ]

Subtotal (95% CI) 14 14 100.0 % -0.90 [ -1.96, 0.16 ]

Heterogeneity: not applicable
Test for overall effect: Z = 1.66 (P = 0.097)

-4 -2 0 2 4
Favours FORSUS Favours elastics

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 Analysis 4.10. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 10 FMA stepwise (SWG) versus FMA single step (SSG).

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 10 FMA stepwise (SWG) versus FMA single step (SSG)

FMA
stepwise FMA single Mean Mean
Study or subgroup (SWG) step (SSG) Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Final overjet
Aras 2017a 17 2.34 (0.7) 17 2.11 (0.75) 100.0 % 0.23 [ -0.26, 0.72 ]

Subtotal (95% CI) 17 17 100.0 % 0.23 [ -0.26, 0.72 ]

Heterogeneity: not applicable
Test for overall effect: Z = 0.92 (P = 0.36)
2 Final ANB
Aras 2017a 17 3.05 (0.79) 17 3.74 (0.7) 100.0 % -0.69 [ -1.19, -0.19 ]

Subtotal (95% CI) 17 17 100.0 % -0.69 [ -1.19, -0.19 ]

Heterogeneity: not applicable
Test for overall effect: Z = 2.70 (P = 0.0070)

-4 -2 0 2 4
Favours FMA stepwise Favours FMA single step

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 Analysis 4.11. Comparison 4 Late orthodontic treatment: different types of appliances used for late
treatment, Outcome 11 Harvold Activator versus Frankel function regulator.

Review: Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents

Comparison: 4 Late orthodontic treatment: different types of appliances used for late treatment

Outcome: 11 Harvold Activator versus Frankel function regulator

Frankel
function Mean Mean
Study or subgroup Harvold Activator regulator Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Overjet change
New Zealand 2000 12 -5.17 (3.75) 13 -2.24 (2.23) 100.0 % -2.93 [ -5.37, -0.49 ]

Total (95% CI) 12 13 100.0 % -2.93 [ -5.37, -0.49 ]

Heterogeneity: not applicable
Test for overall effect: Z = 2.35 (P = 0.019)
Test for subgroup differences: Not applicable

-100 -50 0 50 100

Favours [Harvold Activat] Favours [Frankel function regulator]

APPENDICES

Appendix 1. Cochrane Oral Health’s Trials Register search strategy

From April 2013, searches of Cochrane Oral Health’s Trials Register were conducted using the Cochrane Register of Studies and the
search strategy below:
#1 (orthodontic*:ti,ab) AND (INREGISTER)
#2 ((appliance* or device*):ti,ab) AND (INREGISTER)
#3 ((function* or remov* or fix* or intraoral or “intra oral” or intra-oral or extraoral or “extra oral” or extra-oral):ti,ab) AND (INREG-
ISTER)
#4 ((brace* or band* or wire* or headgear* or “head gear*” or head-gear* ):ti,ab) AND (INREGISTER)
#5 (#2 and #3) AND (INREGISTER)
#6 ((“activator appliance*” or Frankel or “twin* block*” or FR-II or “growth modif*” or “Two phase”):ti,ab) AND (INREGISTER)
#7 ((orthopedic and dental):ti,ab) AND (INREGISTER)
#8 ((orthopaedic and dental):ti,ab) AND (INREGISTER)
#9 (#1 or #4 or #5 or #6 or #7 or #8) AND (INREGISTER)
#10 ((retrognathi* or “posterior occlusion*”):ti,ab) AND (INREGISTER)
#11 ((“class II” and malocclusion*):ti,ab) AND (INREGISTER)
#12 ((distocclusion* or disto-occlusion* or distoclusion* or “prominent upper front teeth” or overjet* or over-jet* or “over jet*”):ti,ab)
AND (INREGISTER)
#13 ((“Class 2” and malocclusion*):ti,ab) AND (INREGISTER)
#14 (#10 or #11 or #12 or #13) AND (INREGISTER)
#15 (#9 and #14) AND (INREGISTER)
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Previous searches of Cochrane Oral Health’s Trials Register were conducted using the Procite software and the search strategy below:
(orthodontic* or (appliance* and (function* or remov* or fix* or intraoral or “intra oral” or intra-oral or extraoral or “extra oral” or
extra-oral)) or brace* or band* or wire* or headgear* or “head gear*” or head-gear* or (device and (function* or remov* or fix* or
intraoral or “intra oral” or intra-oral or extraoral or “extra oral” or extra-oral)) or “activator appliance*” or Frankel or “twin* block*”
or FR-II or “growth modif*” or “Two phase” or (orthopedic and dental) or (orthopaedic and dental)) AND (retrognathi* or “posterior
occlusion*” or (“class II” and malocclusion*) or (“Class 2” and malocclusion*) or distocclusion* or disto-occlusion* or distoclusion*
or “prominent upper front teeth” or overjet* or over-jet* or “over jet*”)

Appendix 2. Cochrane Central Register of Controlled Trials (CENTRAL) search strategy

#1 MeSH descriptor Orthodontics explode all trees
#2 ((appliance* in All Text near/5 function* in All Text) or (appliance* in All Text near/5 remov* in All Text) or (appliance* in All Text
near/5 fix* in All Text) or (appliance* in All Text near/5 intraoral in All Text) or (appliance* in All Text near/5 “intra oral” in All Text)
or (appliance* in All Text near/5 intra-oral in All Text) or (appliance* in All Text near/5 extraoral in All Text) or (appliance* in All Text
near/5 “extra oral” in All Text) or (appliance* in All Text near/5 extra-oral in All Text))
#3 ((device* in All Text near/5 function* in All Text) or (device* in All Text near/5 remov* in All Text) or (device* in All Text near/5
fix* in All Text) or (device* in All Text near/5 intraoral in All Text) or (device* in All Text near/5 “intra oral” in All Text) or (device* in
All Text near/5 intra-oral in All Text) or (device* in All Text near/5 extraoral in All Text) or (device* in All Text near/5 “extra oral” in
All Text) or (device* in All Text near/5 extra-oral in All Text))
#4 (orthodontic* in All Text and (brace* in All Text or band* in All Text or wire* in All Text) )
#5 (orthodontic* in All Text and (extract* in All Text or remov* in All Text) )
#6 (orthodontic* in All Text and (headgear* in All Text or “head gear*” in All Text or head-gear in All Text) )
#7 “activator appliance*” in All Text
#8 (Frankel in All Text or “twin* block*” in All Text or FR-II in All Text)
#9 ( (growth in All Text near/3 modif* in All Text) and (jaw* in All Text or maxilla* in All Text or mandib* in All Text) )
#10 (two-phase in All Text and (treatment in All Text or therapy in All Text) and (orthodontic* in All Text or malocclusion* in All
Text) )
#11 ( (orthopedic* in All Text or orthopaedic* in All Text) and (dental in All Text or orthodontic* in All Text or facial in All Text) )
#12 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11)
#13 MeSH descriptor Malocclusion, Angle Class II this term only
#14 MeSH descriptor Retrognathism this term only
#15 ( (“class II” in All Text near/3 malocclusion* in All Text) or (“class 2” in All Text near/3 malocclusion* in All Text) ) #16 (posterior
in All Text near/3 occlusion* in All Text)
#17 (distoclusion* in All Text or disto-occlusion* in All Text or distocclusion* in All Text)
#18 retrognath* in All Text
#19 “prominent upper front teeth” in All Text
#20 (overjet* in All Text or “over jet*” in All Text or over-jet* in All Text)
#21 (#13 or #14 or #15 or #16 or #17 or #18 or #19 or #20)
#22 (#12 and #21)

Appendix 3. MEDLINE Ovid search strategy

1. exp Orthodontics/
2. (appliance$ adj5 (function$ or remova$ or fix$)).mp.
3. (orthodontic$ and (brace$ or band$ or wire$)).mp.
4. (orthodontic$ and (extract$ or remov$)).mp.
5. (orthodontic$ and (headgear$ or “head gear$” or head-gear$)).mp.
6. (device$ adj5 (function$ or remova$ or fix$)).mp.
7. ((appliance$ or device$) adj5 (intraoral or “intra oral” or intra-oral or extraoral or “extra oral” or extra-oral)).mp.
8. (activator adj appliance$).mp.
9. (Frankel or “twin$ block$” or FR-II).mp.
10. ((growth adj3 modif$) and (jaw$ or maxilla$ or mandible$ or mandibular)).mp.
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11. (two-phase and (treatment or therapy) and (orthodontic$ or malocclusion$)).mp.
12. ((orthopedic$ or orthopaedic$) and (dental or orthodontic$ or facial)).mp.
13. or/1-12
14. Malocclusion, Angle Class II/
15. Retrognathism/
16. ((“class II” or “class 2”) adj3 malocclusion$).mp.
17. (posterior adj3 occlusion$).mp.
18. (distoclusion$ or disto-occlusion$ or distocclusion$).mp.
19. retrognath$.mp.
20. (prominent adj3 upper adj3 teeth).mp.
21. (overjet$ or “over jet$” or over-jet$).mp.
22. or/14-21
23. 13 and 22
The above subject search was linked to the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomised trials in
MEDLINE: sensitivity maximising version (2008 revision) as referenced in Chapter [Link] and detailed in box 6.4.c of theCochrane
Handbook for Systematic Reviews of Interventions, Version 5.1.0 [updated March 2011] (Lefebvre 2011).
1. randomized controlled [Link].
2. controlled clinical [Link].
3. [Link].
4. [Link].
5. drug [Link].
6. [Link].
7. [Link].
8. [Link].
9. or/1-8
10. exp animals/ not [Link].
11. 9 not 10

Appendix 4. Embase Ovid search strategy

1. exp Orthodontics/
2. (appliance$ adj5 (function$ or remova$ or fix$)).mp.
3. (orthodontic$ and (brace$ or band$ or wire$)).mp.
4. (orthodontic$ and (extract$ or remov$)).mp.
5. (orthodontic$ and (headgear$ or “head gear$” or head-gear$)).mp.
6. (device$ adj5 (function$ or remova$ or fix$)).mp.
7. ((appliance$ or device$) adj5 (intraoral or “intra oral” or intra-oral or extraoral or “extra oral” or extra-oral)).mp.
8. (activator adj appliance$).mp.
9. (Frankel or “twin$ block$” or FR-II).mp.
10. ((growth adj3 modif$) and (jaw$ or maxilla$ or mandible$ or mandibular)).mp.
11. (two-phase and (treatment or therapy) and (orthodontic$ or malocclusion$)).mp.
12. ((orthopedic$ or orthopaedic$) and (dental or orthodontic$ or facial)).mp.
13. or/1-12
14. Retrognathia/
15. ((“class II” or “class 2”) adj3 malocclusion$).mp.
16. (posterior adj3 occlusion$).mp.
17. (distoclusion$ or disto-occlusion$ or distocclusion$).mp.
18. retrognath$.mp.
19. (prominent adj3 upper adj3 teeth).mp.
20. (overjet$ or “over jet$” or over-jet$).mp.
21. or/14-20
22. 13 and 21
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The above subject search was linked to adapted version of the Cochrane Embase Project filter for identifying RCTs in Embase Ovid
(see [Link] for information):
1. Randomized controlled trial/
2. Controlled clinical study/
3. Random$.ti,ab.
4. randomization/
5. intermethod comparison/
6. [Link],ab.
7. (compare or compared or comparison).ti.
8. ((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab.
9. (open adj label).ti,ab.
10. ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab.
11. double blind procedure/
12. parallel group$[Link],ab.
13. (crossover or cross over).ti,ab.
14. ((assign$ or match or matched or allocation) adj5 (alternate or group$1 or intervention$1 or patient$1 or subject$1 or partici-
pant$1)).ti,ab.
15. (assigned or allocated).ti,ab.
16. (controlled adj7 (study or design or trial)).ti,ab.
17. (volunteer or volunteers).ti,ab.
18. [Link].
19. or/1-18
20. (exp animal/ or [Link]. or nonhuman/) not (exp human/ or human cell/ or (human or humans).ti.)
21. 19 not 20

Appendix 5. US National Institutes of Health Ongoing Trials Register ([Link]) search

strategy
“class II malocclusion”
retrognath*
overjet or “posterior occlusion”
“prominent upper front teeth”

Appendix 6. World Health Organization International Clinical Trials Registry Platform search
strategy
“class II malocclusion” or “class 2 malocclusion”
retrognath*
overjet or “posterior occlusion”
“prominent upper front teeth”

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WHAT’S NEW
Last assessed as up-to-date: 27 September 2017.

Date Event Description

30 November 2017 New citation required and conclusions have changed The quality of the evidence to support treating promi-
nent upper front teeth in one phase in adolescence (late
treatment with functional appliance versus no treat-
ment) is now ’low’. It was previously ’very low’

27 September 2017 New search has been performed Search updated until 27 September 2017
11 new studies included

HISTORY
Protocol first published: Issue 1, 2002
Review first published: Issue 3, 2007

Date Event Description

4 March 2014 Amended Minor edit to forest plots.

14 November 2013 Amended Minor edit.

7 November 2013 New citation required and conclusions have changed New methods including risk of bias implemented. In-
clusion criteria modified to exclude controlled clinical
trials and quasi-randomised trials. 9 new included tri-
als, conclusions changed. Summary of findings tables
added

7 November 2013 New search has been performed Searches updated to April 2013.

23 June 2008 Amended Converted to new review format.

CONTRIBUTIONS OF AUTHORS
The original review (2007) was conceived by Jayne E Harrison (JH), Kevin D O’Brien (KOB) and Bill Shaw (Cochrane Oral Health).
Sylvia Bickley (Cochrane Oral Health) developed the search strategy and undertook the electronic searches. JH and KOB screened
the search results, retrieved papers and undertook the risk of bias assessment of the papers and data extraction. KOB and Helen V
Worthington (HW) undertook the data analysis. KOB, HW and JH wrote the original review.
The first update (2013) was co-ordinated by Badri Thiruvenkatachari (BT) and KOB. Anne Littlewood (Cochrane Oral Health)
developed the search strategy and undertook the electronic searches. All review authors screened the search results and retrieved papers,
undertook the risk of bias assessment of the papers and extracted data from them. BT and KOB analysed the data and interpreted the
results. BT and KOB wrote the results, conclusions and discussion sections of the review.
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The current update (2017) was co-ordinated by Klaus BSL Batista (KB), BT and KOB. Anne Littlewood (Cochrane Oral Health)
developed the search strategy and undertook the electronic searches. KB, BT and JH screened the search results and retrieved papers,
undertook the risk of bias assessment of the papers and extracted data from them. KB, BT and KOB wrote the results, conclusions and
discussion sections of the review.

DECLARATIONS OF INTEREST
Klaus BSL Batista: no interest to declare.
Kevin O’Brien was involved in acquiring funding, running and reporting of the UK (11-14) 2003, UK (Mixed) 2009 and Banks 2004
trials; however, he was not involved in the quality assessment of these trials.
Badri Thiruvenkatachari and Helen Worthington (author on previous versions) are among the authors of UK (Mixed) 2009; however,
they were not involved in the risk of bias assessment of this trial. Helen V Worthington is a Co-ordinating Editor with Cochrane Oral
Health.
Badri Thiruvenkatachari and Kevin O’Brien were involved in running and reporting the Thiruvenkatachari 2010 (Dynamax) study;
however, they were not involved in the quality assessment of this trial.
Jayne E Harrison: no interest to declare. Dr Harrison is an Editor with Cochrane Oral Health.

SOURCES OF SUPPORT

Internal sources
• The Royal Liverpool and Broadgreen University Hospitals NHS Trust, UK.
• School of Dentistry, The University of Manchester, UK.
• Manchester Academic Health Sciences Centre (MAHSC) and NIHR Manchester Biomedical Research Centre, UK.

External sources
• NHS National Primary Dental Care R&D programme PCD97-303, UK.
• Cochrane Oral Health Global Alliance, Other.
The production of Cochrane Oral Health reviews has been supported financially by our Global Alliance since 2011 (
[Link]/partnerships-alliances). Contributors over the past year have been the American Association of Public Health
Dentistry, USA; the British Association for the Study of Community Dentistry, UK; the British Society of Paediatric Dentistry, UK;
the Canadian Dental Hygienists Association, Canada; the Centre for Dental Education and Research at All India Institute of Medical
Sciences, India; the National Center for Dental Hygiene Research & Practice, USA; New York University College of Dentistry, USA;
NHS Education for Scotland, UK; and the Swiss Society for Endodontology, Switzerland.
• National Institute for Health Research (NIHR), UK.
This project was supported by the NIHR, via Cochrane Infrastructure funding to Cochrane Oral Health. The views and opinions
expressed herein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR,
the NHS or the Department of Health.

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DIFFERENCES BETWEEN PROTOCOL AND REVIEW
In the last update of this review, we decided to include only truly randomised controlled trials. Quasi-randomised trials and controlled
clinical trials were excluded.
In this update, we made minor modifications to the objectives and outcomes for clarity. We added ’and adolescents’ to the title. We
clarified that early treatment was two-phase and that the age range for late treatment was ’around’ 12 to 16 years. We moved New
Zealand study in late treatment category as the authors felt the participants were treated in one phase.

INDEX TERMS

Medical Subject Headings (MeSH)

∗ Orthodontic Appliances, Functional; ∗ Orthodontic Retainers; Age Factors; Extraoral Traction Appliances; Malocclusion, Angle Class
II [∗ therapy]; Orthodontics, Corrective [∗ methods]; Randomized Controlled Trials as Topic; Treatment Outcome

MeSH check words

Adolescent; Child; Humans

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