Ó

Operative Dentistry, 2020, 45-5, E255-E270

A New Dual-cure Universal Simplified

Adhesive: 18-month Randomized

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Multicenter Clinical Trial
E Gomes de Albuquerque  F Warol  F Signorelli Calazans  L Augusto Poubel
S Soares Marins  T Matos  JJ de Souza  A Reis  M de Oliveira Barceleiro  AD Loguercio

Clinical Relevance
Non-carious cervical lesion restorations using a dual-cure universal adhesive in self-etch
and etch-and-rinse mode showed satisfactory clinical performance after 18 months.

SUMMARY Methods and Materials: Fifty patients partici-

pated in this study. Two hundred non-carious
Objectives: The objective of this multicenter,
cervical lesions were restored using the adhe-
double-blind, split-mouth randomized clinical
sive Futurabond U according to four adhesive
trial was to evaluate the clinical performance strategies (n=50 per group): only self-etch
of a new dual-cure universal adhesive system (SEE), selective enamel etching + self-etch
(Futurabond U, Voco GmBH) when applied (SET), etch-and-rinse with dry dentin (ERDry),
using different strategies over a period of 18 and etch-and-rinse with wet dentin (ERWet).
months. After the adhesive application, cavities were
restored using Admira Fusion composite resin.
Elisa Gomes de Albuquerque, DDS, MS, PhD student,
professor, Department of Restorative Dentistry, School of These restorations were evaluated according
Dentistry, Fluminense Federal University, Nova Friburgo,
Jullian J. de Souza, DDS, MS, PhD student, Department of
Brazil
Restorative Dentistry, School of Dentistry, Ponta Grossa
Flavio Warol, DDS, MS, PhD, professor, Department of State University, Ponta Grossa, Brazil
Restorative Dentistry, School of Dentistry, Fluminense
Alessandra Reis, DDS, PhD, professor, Department of Restor-
Federal University, Nova Friburgo, Brazil
ative Dentistry, School of Dentistry, Ponta Grossa State
Fernanda Signorelli Calazan, DDS, MS, PhD, professor, University, Ponta Grossa, Brazil
Department of Restorative Dentistry, School of Dentistry,
Marcos de Oliveira Barceleiro, DDS, MS, PhD, professor,
Fluminense Federal University, Nova Friburgo, Brazil
Department of Restorative Dentistry, School of Dentistry,
Luiz Augusto Poubel, DDS, MS, PhD, professor, Department Fluminense Federal University, Nova Friburgo, Brazil
of Restorative Dentistry, School of Dentistry, Fluminense
*Alessandro Dourado Loguercio, DDS, MS, PhD, professor,
Federal University, Nova Friburgo, Brazil
Department of Restorative Dentistry, School of Dentistry,
Stella Soares Marins, DDS, MSD student, Department of Ponta Grossa State University, Ponta Grossa, Brazil
Restorative Dentistry, School of Dentistry, Fluminense
*Corresponding author: Avenida General Carlos Cavalcan-
Federal University, Nova Friburgo, Brazil
ti, 4748, Ponta Grossa, PR, Brazil. CEP 84010-330; e-mail:
Thalita Matos, DDS, MS, PhD student, Department of [email protected]
Restorative Dentistry, School of Dentistry, Ponta Grossa
https://doi.org/10.2341/19-144-C
State University, Ponta Grossa, Brazil
E256 Operative Dentistry

to FDI World Dental Federation criteria for the The current concepts of minimally invasive tech-
following characteristics: retention/fracture, niques associated with the need for simplification
marginal adaptation, marginal staining, post- have prompted manufacturers to develop more user-
operative sensitivity, and caries recurrence. friendly adhesive systems, by reducing the applica-
Results: After 18 months, only four patients (12 tion steps and shortening the clinical application
months: one patient, n=4 restorations; and 18 time.6,7 The newest adhesives within this philosophy
months: three patients, n=12 restorations) are called ‘‘universal,’’ ‘‘multipurpose,’’ or ‘‘multi-

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mode’’ adhesives.8,9 This new class of adhesives could
were not evaluated. Fourteen restorations
be used as a two-step etch-and-rinse or one-step self-
were lost after 18 months of clinical evaluation
etch, according to the dentist’s preference and
(four for SEE, three for SET, three for ERDry,
professional judgement regarding the selection of
and four for ERWet). The retention rates for 18
the adhesive strategy and number of steps.10,11
months (95% confidence interval) were 92%
(81%-97%) for SEE, 94% (83%-97%) for SET, 94% Although there is no official definition for what
(83%-97%) for ERDry, and 92% (81%-97%) for qualifies an adhesive system as a universal adhesive,
ERWet (p.0.05). Thirty-eight restorations the literature describes it is as a single-bottle
were considered to have minor discrepancies adhesive that performs equally well with any
in marginal adaptation at the 18-month recall adhesion strategy and bonds adequately to tooth
(13 for SEE, 13 for SET, six for ERDry, and six structure as well as different direct and indirect
for ERWet; p.0.05). Fourteen restorations restorative materials.11
were detected as a minor marginal discolor- Universal adhesives are similar to the simplified
ation at the 18-month recall (six for SEE, six for one-step self-etch adhesives but contain specific
SET, one for ERDry, and one for ERWet; functional monomers to provide better bonding to
p.0.05). However, all were considered clinical- the hard dental substrates. The best known of these
ly acceptable. No restorations showed postop- monomers is 10-methacryloyloxydecyl dihydrogen
erative sensitivity or caries recurrence at the phosphate (MDP). Several studies showed that
time. MDP ionically bonds to dentin, forming hydrolyti-
Conclusion: The clinical performance of the cally stable calcium salts on hydroxyapatite (nano-
Futurabond U did not depend on the bonding layering), which promotes a more effective and
strategy used, and it was considered reliable stable bonding in water than that provided by other
after 18 months of clinical evaluation, al- functional monomers.12-14
though more marginal discrepancy was ob- The inclusion of MDP allowed the development of
served in the self-etch group. more hydrophobic (ie, less hydrophilic) adhesives15
as MDP is quite hydrophobic because of its long
INTRODUCTION carbonyl chain.16,17 Due to the inclusion of MDP and
an optimized amount of water content, the manu-
Non-carious cervical lesions (NCCLs) are commonly
facturers claimed to have balanced the hydrophobic
found specific tissue losses. They are reported in up
and hydrophilic properties to ensure bonding at
to 60% of patients and are the most prevalent in the
varying moisture levels.18,19
maxillary posterior teeth, mainly the premolars.1,2
Development of NCCLs is a pathological process Although several universal adhesives have al-
characterized by the loss of dental hard tissues near ready been evaluated and shown reliable results
the cementoenamel junction3 not caused by a through laboratory tests to establish the best
bacterial agent. NCCLs could be caused by tooth- application protocol for universal adhesives,10,20,21
brush abrasion, erosion caused by acids, and abfrac- it is known that only clinical evaluations are the
tion due to occlusal problems.4 Recently, there have ultimate proof of clinical efficacy.22
been worldwide increases in the prevalence and Because of all these features, the clinical use of
severity of NCCLs closely associated with people’s universal adhesives is increasing rapidly, and sev-
lifestyles and the aging of the population.5 Because eral clinical studies evaluating the universal adhe-
NCCLs have been associated with other conditions, sive systems were published with significant contro-
such as dentin hypersensitivity and gingival reces- versies.23-30 For instance, some studies26,30 showed
sion, as well as the loss of the dental mineralization that a better clinical performance was observed
continuum,5 the restorative procedure is highly when the universal adhesives were applied in the
recommended.6 etch-and-rinse approach. On the other hand, other
de Albuquerque & Others: Dual-cure Universal Simplified Adhesive—18-month Trial E257

clinical studies showed that there were no differenc- in each university (Figure 1). The evaluations were
es for the universal adhesives applied in the self-etch performed using a mouth mirror, an explorer, and a
or etch-and-rinse mode after 18-36 months of clinical periodontal probe. Participants had to be in good
service.23-25,28,29 The same controversial results general health, be at least 18 years old, have an
could be observed in the conclusion of the authors acceptable oral hygiene level, and present at least 20
of two systematic reviews of clinical studies evalu- teeth under occlusion.
ating universal adhesives,11,31 which indicates the Participants were required to have at least four

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need for more clinical studies to evaluate this new NCCLs to be restored in four different teeth. These
class of adhesive system.
lesions had to be nonretentive, be deeper than 1 mm,
Therefore, the objective of this multicenter, dou- and involve both the enamel and dentin of vital teeth
ble-blind, randomized clinical trial was to evaluate without mobility. The cavosurface margin could not
the clinical behavior of a new dual-cure universal involve more than 50% of enamel.33 Patients who
adhesive when applied using different application had extremely poor oral hygiene used orthodontic
strategies during 18 months of clinical evaluation. devices, had severe or chronic periodontitis, or had
The null hypothesis tested was that bonding to heavy bruxism habits were excluded from the study
NCCLs using the self-etch strategy, compared to as they would need to receive other treatments
selective enamel etching or using the etch-and-rinse before restorative intervention. Also, participants
strategy with adhesive application on dry or moist with known allergy to resin-based materials or any
dentin, would result in similar retention levels over other material used in this study, pregnant or
18 months of clinical service. breastfeeding women, or participants under chronic
use of anti-inflammatory, analgesic, and psychotro-
METHODS AND MATERIALS pic drugs were not be included in the study.
Study Design
The description of the experimental design followed Sample-size Calculation
the Consolidated Standards of Reporting Trials The annual retention rate for one-step self-etch
(CONSORT) statement.32 Written informed consent adhesives in NCCLs was reported to be 4.4% in a
was obtained from all participants prior to starting recent systematic review.6 Considering that this
the treatment. This clinical trial was registered in decline follows a linear trend, the overall retention
clinicaltrial.gov clinical registry (#NCT03244124). rate of one-step self-etch adhesives is approximately
All participants were informed about the nature 78% after 5 years of clinical service. With an a of
and objectives of the study, but they were not aware 0.05, a power of 80%, and a two-sided test, the
of which tooth received the specific treatments under minimal sample size was 50 restorations in each
evaluation. group in order to detect a difference of 25% among
the test groups.
Trial Design, Settings, and Location of Data
Collection Random Sequence Generation and Allocation
This was a multicenter, double-blind, superiority, Concealment
split-mouth, randomized clinical trial. The study was The randomization was done on an intraindividual
carried out in the clinics of the School of Dentistry of basis so that each subject ended up with four
the State University of Ponta Grossa (PR, Brazil) restorations, each one resulting from one of all
and the Federal University Fluminense (Polo de possible combinations of adhesive strategy and
Nova Friburgo, RJ, Brazil) from October 2016 to roughening procedure. These randomization schemes
November 2016. were performed using software available at http://
Recruitment—Patients were recruited as they www.sealedenvelope.com.
sought treatment in the dental clinics of both A staff member not involved in the research
universities. No advertisement was used for partic- protocol performed the randomization process with
ipant recruitment. Patients were recruited in the computer-generated tables. Details of the allocated
order in which they reported for the screening groups were recorded on cards contained in sequen-
session, thus forming a sample of convenience. tially numbered, opaque, sealed envelopes. Opening
Eligibility Criteria—A total of 120 participants the envelope only on the day of the restorative
were examined by two calibrated dental residents to procedure guaranteed concealment of the random
check if they met the inclusion and exclusion criteria sequence. In all cases, the tooth with the highest
E258 Operative Dentistry

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Figure 1. Flowchart of the experimental design.

tooth number received the treatment described first, depth), the geometry of the cavity (evaluated by
whereas the tooth with the next number in sequence profile photograph and labeled at ,458, 458 to 908,
received the treatment mentioned second, with 908 to ,1358, and .1358),35 the presence of an
placement continuing in a similar manner until the antagonist, and the presence of attrition facets were
fourth tooth (for the patients with four teeth needing observed and recorded. Preoperative sensitivity was
treatment). All restorations in the same subject were also evaluated by applying air for 10 seconds from a
always placed in different sextants. dental syringe placed 2 cm from the tooth surface
and with an explorer. These features were recorded
Interventions: Restorative Procedure to allow comparison of the baseline features of the
All the patients selected for this study received dentin cavities among experimental groups.
dental prophylaxis with a suspension of pumice and To calibrate the restorative procedure, the study
water in a rubber cup and signed an informed director of each center (MOB and ADL) placed one
consent form two weeks before the restorative restoration from each group to identify all steps
procedures. The degree of sclerotic dentin from the involved in the application technique. Then, the four
NCCLs was measured according to the criteria operators (EGA, FW, TM and JJS), who were
described by Swift and others34 (Table 1). The cavity resident dentists with more than five years of clinical
dimensions in millimeters (height, width, and experience in operative dentistry, two in each center,
de Albuquerque & Others: Dual-cure Universal Simplified Adhesive—18-month Trial E259

Table 1: Dentin Sclerosis Scalea

for 5 seconds and light cured for 10 seconds at 1200
mW/cm2 (Bluephase 20i, Ivoclar Vivadent, Schaan,
Category Criteria Liechtenstein).
1 No sclerosis present; dentin is light yellowish or
whitish, with little discoloration; dentin is opaque, with Self-etch Associated With Selective Enamel Etch-
little translucency or transparency ing Group (SET)—The 35% phosphoric acid (Voco-
2 More sclerosis than in category 1 but less than cid, Voco) was applied for 30 seconds only in enamel.
halfway between categories 1 and 4 Then, cavities were rinsed and air-dried, until dentin

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3 Less sclerosis than in category 4 but more than was kept visibly dry. The adhesive system was
halfway between categories 1 and 4 applied as described in the self-etch group (Table
4 Significant sclerosis present; dentin is dark yellow or 3). Solvent evaporation and light curing procedures
even discolored (brownish); glassy appearance, with
were also the same.
significant translucency or transparency evident
a
Adapted from Swift and others.34 Etch-and-rinse Dry Dentin Group (ERDry)—The
35% phosphoric acid (Vococid) was applied for 30
seconds (enamel) and 15 seconds (dentin). Then,
placed four restorations, one of each group, under
cavities were rinsed and air-dried, until dentin was
the supervision of the study director in a clinical
kept visibly dry. The adhesive system was applied as
setting. The restoration failures were shown to the
described in the self-etch group (Table 3). Solvent
operators before starting the study. At this point, the
evaporation and light curing procedures were also
operators were considered calibrated to perform the
the same.
restorative procedures. The operators restored all
teeth. All participants received four restorations, one Etch-and-rinse Wet Dentin Group (ERWet)—The
for each experimental group in different lesions 35% phosphoric acid (Vococid) was applied for 30
previously selected according to the inclusion crite- seconds (enamel) and 15 seconds (dentin). Then,
ria. cavities were rinsed and slightly air-dried, keeping
visible dentin moist. The adhesive system was
Before restorative procedures, the operators anes-
applied as described in the self-etch group (Table
thetized the teeth with a 3% mepivacaine solution
3). Solvent evaporation and light curing procedures
(Mepisv, Nova DFL, Rio de Janeiro, Brazil) and
were also the same.
cleaned all lesions with pumice and water in a
rubber cup (No. 8040RA and No. 8045RA, KG After adhesive application, the resin composite
Sorensen, Barueri, Brazil) followed by rinsing and Admira Fusion unidose (Voco) was used in up to
drying. Then, shade selection was made using a three increments, inserted directly in the cavity with
shade guide. After a rubber dam was placed, the new a Centrix device (Centrix, Shelton, CT, USA) and
universal adhesive system Futurabond U (Voco, each one being light cured for 10 seconds at 1200
GmbH, Cuxhaven, Germany) was applied as de- mW/cm2. The restorations were finished immediate-
scribed later. The compositions, application modes, ly with fine and extra-fine No. 2200 diamond burs
and batch numbers are described in Tables 2 and 3. (KG Sorensen) and polished with Jiffy polisher
(Ultradent) under constant water-cooling.
Self-etch Group (SEE)—One coat of adhesive was
gently scrubbed on the entire enamel and dentin
surface for approximately 20 seconds, according to Calibration Procedures for Clinical Evaluation
the manufacturer’s recommendations (Table 3). The For training purposes, two experienced and calibrat-
adhesive was then evaporated by gentle air stream ed examiners in each center (FSC, LAP, AR and

Table 2: Composition and Batch Number of Materials Used in the Restorative Procedures
Material (Manufacturer) Batch Number Composition
Futurabond U 1609415 35% phosphoric acid (Vococid): 35% phosphoric acid
(Voco GmbH, Cuxhaven, Germany) Adhesive: HEMA, Bis-GMA, HEDMA, acidic adhesive monomer,a urethane
dimethacrylate, catalyst, silica nanoparticles, ethanol
Admira Fusion Shade A2: 1607524; Resin matrix: aromatic and aliphatic dimethacrylates, methacrylate-functionalized
(Voco GmbH, Cuxhaven, Germany) Shade A3: 1606252; polysiloxane
Shade A3,5: 1605482 Inorganic filler: Ba-Al-glass, pyrogenic SiO2, filler load: 78 mass %.
Photoinitiator: camphorquinone. Synergist: NI
Abbreviations: Bis-GMA: Bisphenol-A-glycidyl dimethacrylate; HEDMA: 1,6-hexanediol dimethacrylate; HEMA: 2-hydroxyethyl methacrylate.
a
Acidic adhesive monomer in the composition of Futurabond U is 10-MDP: 10-methacryloyloxydecyl dihydrogen phosphate according to personal communication with
Dr Martin Danebrock (January 30, 2018)
E260 Operative Dentistry

a
Table 3: Application Mode of the Adhesive System in the Groups
Group Application Mode
Etch Adhesive Resin Composite
Self-etch (SEE) No Keep dentin dry 1. Activate single-dose Insert in the cavity at increases
Self-etch associated Apply etchant only in (do not over dry) adhesive package; of up to 1 mm and light-cure
to selective enamel enamel (30 s), rinse 2. Apply adhesive to each area of the surface of the
etching (SET) for 30 s, air dry to the cavity surface with restoration with a dental curing

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remove excess water Voco Single Tim Brush light appliance (wavelength of
for 20 s with vigorous 470 nm, light power of
Etch-and-rinse, Apply etchant in agitation; 1200 mW/cm2) for 30 s.
dentin dry (ERDry)b enamel (30 s) and 3. Gently air dry for 5 s;
Etch-and-rinse, dentin (15 s), rinse Keep dentin wet 4. Light cure for 10 s
dentin wet (ERWet) for 30 s, air dry to at 1200 mW/cm2.
remove excess water
a
According to the manufacturer’s instructions.
b
Manufacturer does not indicate application in dry dentin.

ADL) observed 10 photographs that were represen- and marginal adaptation, the semiquantitative cri-
tative of each score for each criterion. They evaluat- teria (SQUACE) proposed by Hickel and others37,38
ed 10 to 15 patients each on two consecutive days. was used. Each evaluator outlined the extent of the
These subjects had cervical restorations but were not observed event on the sketch of each restoration
part of this project. An intraexaminer and interexa- using a pen according to defined criteria (marginal
miner agreement of at least 85% was necessary staining and marginal adaptation); after that, each
before beginning the evaluation.36 margin was assessed quantitatively as a proportion
BlindingThe examiners were not involved with of the total length of the margin. Also, all mentioned
the restoration procedures and therefore blinded to variables previously described were evaluated by
the group assignment. Patients were also blinded to USPHS criteria into Alpha, Bravo, and Charlie.36
group assignment in a double-blind randomized Both examiners evaluated all the restorations once
clinical trial design. and independently. When disagreements occurred
Clinical EvaluationAn individual, standardized, during the evaluations, they had to reach a consen-
paper case report form was used for each evaluator sus before the participant was dismissed. The
at each recall time so that evaluators were kept restoration retention rates were calculated according
blinded to earlier evaluations during the follow-up to the American Dental Association guidelines.40
recalls. The restorations were evaluated by FDI Cumulative failure percentage = [(PF þ NF) / (PF þ
World Dental Federation criteria37,38 and the classi- RR)] 3 100%, where PF is the number of previous
cal US Public Health Service (USPHS) criteria failures before the current recall, NF is the number
(adapted by Bittencourt and others39) at baseline of new failures during the current recall, and RR is
and after 6,12, and 18 months of clinical service. the number of currently recalled restorations.
Only the clinically relevant measures for evaluation
of adhesive performance were used and scored Statistical Analysis
(Tables 4 and 5). The primary clinical endpoint was The statistical analyses followed the intention-to-
restoration retention/fracture, but the following treat protocol according to CONSORT (Consolidated
secondary endpoints were also evaluated: marginal Standards of Reporting Trials) suggestion.32 De-
staining, marginal adaptation, postoperative sensi- scriptive statistics were used to describe the distri-
tivity, and recurrence of caries. The evaluation of butions of the evaluated criteria. Statistical analysis
spontaneous postoperative sensitivity was per- for each individual item was performed for each
formed one week after the restorative procedure by evaluation criteria (FDI and USPHS criteria). The
asking patients if they experienced any pain during differences in the ratings of the four groups after 6,
the period. 12, and 18 months were tested with the Friedman
These variables were ranked according to FDI repeated-measures analysis of variance by rank, and
criteria into clinically very good, clinically good, differences in the ratings of each group at baseline
clinically sufficient/satisfactory, clinically unsatis- and after 6, 12, and 18 months were evaluated using
factory but repairable, and clinically poor (replace- the Wilcoxon test. Data from SQUACE after 18
ment required).37,38 In the case of marginal staining months of clinical service was evaluated with the
de Albuquerque & Others: Dual-cure Universal Simplified Adhesive—18-month Trial E261

Table 4: FDI Criteria Used for Clinical Evaluation37,38

Esthetic Functional Properties Biological Properties
Properties
1. Staining Margin 2. Fractures and 3. Marginal 4. Postoperative 5. Recurrence of
Retention Adaptation (Hyper-)sensitivity Caries
1. Clinically very good 1.1 No marginal 2.1 Restoration 3.1 Harmonious 4.1 No 5.1 No secondary or
(A) staining retained, no outline, no gaps, no hypersensitivity primary caries

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fractures/cracks discoloration
2. Clinically good (B) 1.2 Minor marginal 2.2 Small hairline 3.2.1 Marginal gap 4.2 Low 5.2 Very small and
(after correction very staining, easily crack (50 lm). hypersensitivity for localized
good removable by 3.2.2 Small a limited period of demineralization.
polishing marginal fracture time No operative treatment
removable by required
polishing
3 Clinically sufficient/ 1.3 Moderate 2.3 Two or more or 3.3.1 Gap ,150 lm 4.3.1 Premature/ 5.3 Larger areas of
satisfactory (C) marginal staining, larger hairline not removable slightly more demineralization, but
(minor shortcomings not esthetically cracks and/or 3.3.2. Several small intense only preventive
with no adverse unacceptable chipping (not enamel or dentin 4.3.2 Delayed/weak measures are
effects but not affecting the fractures sensitivity; no necessary (dentin not
adjustable without marginal integrity) subjective exposed)
damage to the tooth) complaints, no
treatment needed
4. Clinically 1.4 Pronounced 2.4 Chipping 3.4.1 Gap .250 lm 4.4.1 Premature/ 5. 4 Caries with
unsatisfactory (D) marginal staining; fractures, which or dentin/base very intense cavitation (localized
(repair for major intervention damage marginal exposed. 4.4.2 Extremely and accessible and
prophylactic necessary for quality; bulk 3.4.2. chip fracture delayed/weak with can be repaired)
reasons) improvement fractures with or damaging margins subjective
without partial loss 3.4.3 Notable complaints
(less than half of enamel or dentin 4.4.3 Negative
the restoration) wall fracture sensitivity;
intervention
necessary but not
replacement
5. Clinically poor (E) 1.5 Deep marginal 2.5 (Partial or 3.5 Filling is loose 4.5 Very intense, 5.5 Deep secondary
(replacement staining not complete) loss of but in situ acute pulpitis or caries or exposed
necessary) accessible for restoration nonvital; endodontic dentin that is not
intervention treatment is accessible for repair of
necessary and restoration
restoration has to
be replaced

Table 5: Modified USPHS Criteria According to Bittencourt and Others39

Marginal Retention Fracture Marginal Postoperative Recurrence of
Staining Adaptation Sensitivity caries
Alpha No discoloration Retained None Restoration is No postoperative None evidence of
along the margin continuous with sensitivity directly caries contiguous
existing anatomic after the restorative with the margin
form process and during
the study period
Bravo Slight and Partially retained Small chip, but Detectable V-shaped - -
superficial staining clinically acceptable defect in enamel
(removable, usually only; catches explorer
localized) going both ways
Charlie Deep staining Missing Failure due to bulk Detectable V-shaped Sensitivity present Evidence of
cannot be polished restorative fracture defect to dentin- at any time during presence of caries
away enamel junction the study period
E262 Operative Dentistry

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Figure 2. Examples of restorations after baseline and 18 months of clinical evaluation. All restorations were scored as clinically very good at baseline
(A-D; FDI criteria). Teeth 23 (E; ErWet group), 12 (F; SET group), 28 (G; ErDry group), and 29 (G; SEE group) were scored as clinically very good (FDI
criteria for marginal adaptation). Teeth 24 (E; SET group), 13 (F; SEE group), and 6 (H; ErWet group) were scored as clinically good (FDI criteria for
marginal adaptation). Tooth 5 was scored as clinically poor (H; ErDry group; FDI criteria for marginal adaptation).

Kruskall-Wallis test. The Cohen kappa statistic was ing to both evaluation criteria, the 6-month retention
used to test interexaminer agreement. In all statis- rates (95% confidence interval [CI]) were 96% (86%-
tical tests, we preset the level of significance to 5%. 98%) for SEE, 98% (89%-99%) for SET, 98% (89%-
99%) for ERDry, and 94% (83%-97%) for ERWet with
RESULTS no statistical difference identified between any pair
General Results of groups (p.0.05; Tables 7 and 8). When the data
from the 6-month results from each group were
The restorative procedures were implemented exactly
compared with the baseline findings, no significant
as planned, and no modification was performed. Of
difference was found (p.0.05; Tables 7 and 8).
the 120 patients examined for eligibility, 70 were not
enrolled in the study because they did not fulfill the Ten restorations were lost or fractured after 12
inclusion criteria. Thus, a total of 50 subjects (23 men months of clinical evaluation (two for SEE, three for
and 27 women) were selected. Two hundred restora- SET, two for ERDry, and three for ERWet). Accord-
tions were placed, 50 for each group (Figure 1). ing to both evaluation criteria, the 12-month reten-
All baseline details relative to the research tion rates (95% CI) were 96% (86%-98%) for SEE,
subjects and characteristics of the restored lesions 94% (83%-97%) for SET, 96% (86%-98%) for ERDry,
are displayed in Table 6. The overall Cohen kappa and 94% (83%-97%) for ERWet with no statistical
statistic showed excellent agreement between the difference identified between any pair of groups
examiners at the 6-, 12-, and 18-month (0.82) follow- (p.0.05; Tables 7 and 8). When the data from the 12-
ups. All research subjects were evaluated at baseline month results from each group were compared with
and at the 6-month recall. One subject moved to a the baseline findings, no significant difference was
new city and was not included in the 12-month recall found (p.0.05; Tables 7 and 8).
rate, and another three subjects did not attend Fourteen restorations were lost after 18 months of
the18-month recall. Some examples of restorations clinical evaluation (four for SEE, three for SET,
after baseline and 18 months of clinical evaluation three for ERDry, and four for ERWet). According to
are depicted in Figure 2. both evaluation criteria, the 18-month retention
rates (95% CI) were 92% (81% to 97%) for SEE,
Retention/Fracture 94% (83% to 97%) for SET, 94% (83% to 97%) for
Seven restorations were lost or fractured after 6 ERDry, and 92% (81% to 97%)for ERWet, with no
months of clinical evaluation (two for SEE, one for statistical difference identified between any pair of
SET, one for ERDry, and three for ERWet). Accord- groups (p.0.05; Tables 7 and 8). When the data from
de Albuquerque & Others: Dual-cure Universal Simplified Adhesive—18-month Trial E263

Table 6: Characteristics of the Research Participants and

the 18-month results from each group were com-
the NCCLs by Experimental Group pared with the baseline findings, no significant
difference was found (p.0.05; Tables 7 and 8).
Characteristics of No. of
Research Participants Participants
Gender distribution
Marginal Adaptation
Male 23 Twenty-four restorations were considered to have
Female 27 minor discrepancies in marginal adaptation at the 6-

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Age distribution (y) month recall using the FDI criteria (eight for SEE,
20-29 3 nine for SET, four for ERDry, and three for ERWet;
30-39 3 Table 7). No significant difference was detected
39-49 20 between any pair of groups at the 6-month recall
.49 24 for either evaluation criteria (p.0.05; Table 7).
Characteristics No. of Lesions
When the USPHS criteria were used, three restora-
of NCCLs SEE SET ERDry ERWet
tions were scored as Bravo for marginal adaptation
Shape (degree of angle)
(two for SEE and one for SET; p.0.05; Table 8).
When the baseline and 6-month data from the FDI
,45 0 0 0 0
evaluation were compared, a significant difference
45-90 8 10 13 6
was only observed between SEE and SET (p,0.05;
90-135 17 13 15 17
Table 8). No significant difference was detected
.135 25 27 22 27
when the baseline and 6-month data were compared
Cervico-incisal height (mm)
for ERDry and ERWet (p.0.05; Table 8).
,1.5 14 17 17 15
1.5-2.5 15 13 14 17
Thirty-one restorations were considered to have
2.5-4.0 12 8 12 11
minor discrepancies in marginal adaptation at the
12-month recall using the FDI criteria (12 for SEE,
.4.0 9 12 7 7
10 for SET, five for ERDry, and four for ERWet;
Degree of sclerotic dentin
Table 7). No significant difference was detected
1 29 28 28 31
between any pair of groups at the 12-month recall
2 13 14 11 11
for either evaluation criteria (p.0.05; Table 7).
3 6 7 9 6
When the USPHS criteria were used, nine restora-
4 2 1 2 2
tions were scored as Bravo for marginal adaptation
Presence of antagonist
(four for SEE, three for SET, one for ERDry, and one
Yes 41 49 42 44 for ERWet; p.0.05; Table 8). When the baseline and
No 9 1 8 6 12-month data from the FDI evaluation were
Attrition facet compared, a significant difference was observed only
Yes 37 38 40 43 between SEE and SET (p,0.05; Table 8). No
No 13 12 10 7 significant difference was detected when the base-
Preoperative sensitivity (spontaneous) line and 12-month data were compared for ERDry
Yes 13 11 11 13 and ERWet (p.0.05; Table 8).
No 37 39 39 37
Thirty-eight restorations were considered to have
Preoperative sensitivity (air dry)
minor discrepancies in marginal adaptation at the
Yes 17 13 13 15 18-month recall using the FDI criteria (13 for SEE,
No 33 37 37 35 13 for SET, six for ERDry, and six for ERWet; Table
Tooth distribution 7). When the baseline and 18-month data from the
Anterior FDI evaluation were compared, a significant differ-
Incisor 9 12 10 11 ence was observed only between SEE and SET
Canines 8 5 10 9 (p,0.05; Table 7). No significant difference was
Posterior detected when the baseline and 18-month data were
Premolar 21 24 23 21 compared for ERDry and ERWet (p.0.05; Table 7).
Molar 12 9 7 9 When the USPHS criteria were used, 16 restorations
Arch distribution were scored as Bravo for marginal adaptation (six for
Maxillary 25 27 24 26 SEE, six for SET, two for ERDry, and two for ERWet;
Mandibular 25 23 26 24 p.0.05; Table 8). No significant difference was
detected when the baseline and 18-month data from
Abbreviations: ERDry, etch-and-rinse, dry dentin; ERWet, etch-and-rinse,
wet dentin; NCCL, non-carious cervical lesion; SEE, self-etch without
selective enamel etching; SET, self-etch with selective enamel etching.
E264 Operative Dentistry

Table 7: Number of Evaluated Restorations for Each Experimental Group Classified According to FDI Criteria37,38
FDI Criteria Statusa 6 Months 12 Months 18 Months
SEE SET ERDry ERWet SEE SET ERDry ERWet SEE SET ERDry ERWet
Marginal staining A 48 49 49 47 42 41 45 44 32 33 39 37
B - - - - 03 04 01 01 06 06 01 01
C - - - - - - - - - - - -

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D - - - - - - - - - - - -
E - - - - - - - - - - - -
Fractures and retention A 48 49 49 47 45 45 46 45 38 39 40 38
B - - - - - - - - - - - -
C - - - - - - - - - - - -
D - - - 01 - - 01 01 - - - -
E 02 01 01 02 02 03 01 02 04 03 03 04
Marginal adaptation A 40 40 45 44 33 35 41 41 25 26 34 32
B 08 09 04 03 12 10 05 04 10 11 06 06
C - - - - - - - - 03 02 - -
D - - - - - - - - - - - -
E - - - - - - - - - - - -
Postoperative (hyper-) sensitivity A 48 49 49 47 45 45 46 45 38 39 40 38
B - - - - - - - - - - - -
C - - - - - - - - - - - -
D - - - - - - - - - - - -
E - - - - - - - - - - - -
Recurrence of caries A 48 49 49 47 45 45 46 45 38 39 40 38
B - - - - - - - - - - - -
C - - - - - - - - - - - -
D - - - - - - - - - - - -
E - - - - - - - - - - - -
Abbreviations: FDI, World Dental Federation; ERDry, etch-and-rinse, dry dentin; ERWet, etch-and-rinse, wet dentin; SEE, self-etch without selective enamel etching;
SET, self-etch with selective enamel etching.
a
A, clinically very good; B, clinically good; C, clinically sufficient / satisfactory; D, clinically unsatisfactory; E, clinically poor.

the USPHS evaluation criteria were compared tions (one for SEE and one for SET; Table 8) were
(p.0.05; Table 7). No significant difference was considered to show marginal discoloration. When the
detected between any pair of groups at the 18-month baseline and 12-month data for both criteria were
recall for either evaluation criteria (p.0.05; Tables 7 compared, no significant difference was detected
and 8). At the 18-month evaluation, the results of (p.0.05; Tables 7 and 8).
SQUACE showed that, usually, the marginal dis-
After 18 months of clinical evaluation, 14 restora-
crepancy was observed in less than 10% or between
tions were detected with a minor marginal discolor-
10% and 30% of the restorations’ margins (Table 9).
Only the SEE group showed a statistical difference ation using the FDI criteria (six for SEE, six for SET,
at the 18-month recall, compared with other exper- one for ERDry, and one for ERWet; Table 7). When
imental groups (p.0.05; Table 9). USPHS criteria were applied, only four restorations
(two for SEE and two for SET; Table 8) were
Marginal Discoloration considered to show marginal discoloration. When
the baseline and 18-month data for both criteria
Marginal staining was not observed in any restora- were compared, no significant difference was detect-
tion at the 6-month recall using the FDI and USPHS
ed (p.0.05; Tables 7 and 8).
criteria. However, nine restorations presented with
minor marginal discoloration at the 12-month recall
Other Parameters
using the FDI criteria (three for SEE, four for SET,
one for ERDry, and one for ERWet; Table 7). When No restorations had postoperative sensitivity to air
the USPHS criteria were applied, only two restora- at the 6-, 12-, and 18-month recalls using both
de Albuquerque & Others: Dual-cure Universal Simplified Adhesive—18-month Trial E265

Table 8: Number of Evaluated Restorations for Each Experimental Group According to the Modified USPHS Criteria39
USPHS Criteria 6 Months 12 Months 18 Months
SEE SET ERDry ERWet SEE SET ERDry ERWet SEE SET ERDry ERWet
Marginal staining
Alpha 48 49 49 47 44 44 46 45 36 37 40 38
Bravo - - - - 01 01 - - 02 02 - -

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Charlie - - - - - - - - - - - -
Retention
Alpha 48 49 49 47 45 45 46 45 38 39 40 38
Bravo - - - - - - - - - - - -
Charlie 02 01 01 02 02 03 01 02 04 03 03 04
Fractures
Alpha 48 49 49 47 45 45 46 45 38 39 40 38
Bravo - - - - - - - - - - - -
Charlie - - - 01 - - 01 01 - - - -
Marginal adaptation
Alpha 46 48 49 47 41 42 45 44 32 33 38 36
Bravo 02 01 - - 04 03 01 01 06 06 02 02
Charlie - - - - - - - - - - - -
Postoperative (hyper-) sensitivity
Alpha 48 49 49 47 45 45 46 45 38 39 40 38
Bravo - - - - - - - - - - - -
Charlie - - - - - - - - - - - -
Recurrence of caries
Alpha 48 49 49 47 45 45 46 45 38 39 40 38
Bravo - - - - - - - - - - - -
Charlie - - - - - - - - - - - -
Abbreviations: USPHS, US Public Health Service; ERDry, etch-and-rinse, dry dentin; ERWet, etch-and-rinse, wet dentin; SEE, self-etch without selective enamel
etching; SET, self-etch with selective enamel etching.

criteria. No restoration showed a recurrence of caries which is an objective and clinically important
after 6, 12, and 18 months for either criteria. outcome for adhesive efficacy.6,41 This is considered
a true endpoint because if restorations are lost, none
DISCUSSION of the other parameters can be evaluated. The
results of the present study showed that after 18
The comparison of bonding techniques and adhesive
months of clinical service, restorations placed with
systems is usually performed with NCCLs, as these
Futurabond U had similar retention rates regardless
lesions lack macromechanical retention; therefore,
of the use of phosphoric acid or wetness in the
restoration loss occurs due to ineffective bonding,
surface of the dental substrate of NCCLs; this leads
us to accept the null hypothesis.
Table 9: Number of Evaluated Restorations for Each
In the present study, Futurabond U was applied
Experimental Group According to the Adhesive
Classified by SQUACE criteriaa,37,38 after etching with phosphoric acid under dry or wet
dentin (ERDry and ERWet) conditions. This took
SQUACE criteria SEE SET ERDry ERWet
into account that the ideal universal adhesive would
Less than 10% 02 12 05 05 be one in which bonding to the tooth would not be
Between 10% and 30% 11 01 01 01 influenced by clinically plausible variations in the
Between 31% and 50% - - - - surface moisture.19 Unfortunately, although the wet-
Statistical Analysis B A A A bonding technique is very popular among clinicians,
Abbreviations: ERDry, etch-and-rinse, dry dentin; ERWet, etch-and-rinse, the manufacturers’ instructions for the surface
wet dentin; SEE, self-etch without selective enamel etching; SET, self-etch
with selective enamel etching; SQUACE, semiquantitative criteria.
wetness of the substrates after phosphoric acid
a
Different capital letters indicate statistically significant difference between etching are not precisely specified, making variabil-
groups (p,0.05).
ity in the clinic even more likely.42,43
E266 Operative Dentistry

The rationale behind the wet-bonding technique is, extrapolation to clinical situations is not often
after phosphoric acid etching (etch-and-rinse tech- recommended, the available research data suggest
nique), it is important to keep the dentin moist to that etching dentin may not be the first choice for
avoid the collapse of the exposed collagen matrix and, MDP-containing universal adhesives.27
mainly, to guarantee the infiltration of the resin In the safety data sheet of Futurabond U the
monomer into the demineralized dentin.44 However, manufacturer describes its functional monomer only
universal adhesives contain water in their composi- as a phosphate mono-methacrylate, and this caused

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tion to enable the self-etching potential, and several some confusion in previously published laboratory
studies have already claimed that adhesives with a studies51. However, it has already been confirmed
water concentration of 10% to 25% can re-expand the that MDP is present in the Futurabond U composi-
air-dried and collapsed collagen mesh to facilitate tion,52 and this could be responsible for the higher
adhesive resin infiltration.19,45,46 Therefore, keeping retention rate of Futurabond U when applied in the
the dentin wet or visibly dry after the phosphoric acid self-etch mode (SEE and SET) after 18 months of
application would not make a difference in the clinical service, which is similar to the other
bonding quality when using a universal adhesive universal adhesives available on the market.23-25,29
with this water concentration in the composition.
Unfortunately, the exact water content of the Futur- A frequent concern regarding universal adhesives
abond U was not disclosed by the manufacturer. when used in the self-etch mode is related to the
lower potential of etching enamel,53,54 resulting in a
It is worth mentioning that the active application higher number of defective margins of the restora-
of Futurabond U also helps to infiltrate the adhesive tions and, consequently, the marginal staining at
in the collapsed collagen network because the long-term follow-ups. In the present study, a closer
pressure of the collapsed collagen in demineralized view regarding the marginal adaptation data, main-
dentin allows better monomer diffusion inward as ly from the SEE group, showed that Futurabond U
well as solvent diffusion outward.47,48 The active presented a lower percentage of marginal failures
application of the etch-and-rinse adhesives showed (30%) than found in previous studies when the SEE
better clinical performance in adhesive restorations, group was evaluated (47% to 57%).23,24 Although
even when the dentin was kept visibly dry, compared Futurabond U could be considered a mild pH, self-
with passive application.33,49 etch adhesive (pH range 2-2.5), the adhesives
The results of the present study allowed us to evaluated in previous studies23,24 are considered
conclude that Futurabond U is tolerant to dentin ultra-mild self-etch (pH.2.5). Therefore, it would be
moisture variation because of the similar retention expected that Futurabond U should more adequately
rate of Futurabond U when applied on dry dentin etch the enamel margins. However, no differences
(ERDry; 94%) or moist dentin (ERWet; 92%) after 18 were observed in the enamel etching pattern when
months of clinical evaluation. Compared with the the mild and ultra-mild universal self-etch adhesives
literature, the clinical behavior of Futurabond U were compared.19,53,55 Actually, Futurabond U
when applied in the ERDry or ERWet condition showed similar bonding properties to the enamel
could be considered very good and comparable to the (bond strength and in situ degree of conversion)
universal adhesives evaluated in the same condi- compared with the ultra-mild universal adhesives
tions.23,26 applied in the self-etch mode.24,53
As discussed in the Introduction, the presence of Several factors may be involved in the good
specific functional monomers, such as MDP, in the marginal adaptation of a resin composite to the
universal adhesives is responsible for the chemical cavity. It was shown that the marginal cavity
interaction with the dental hard tissues. Unfortu- adaptation of resin restorations depends not only
nately, the use of phosphoric acid removes the on material-related properties, such as the adhesive
calcium from dentin and may preclude any potential used, polymerization shrinkage, viscoelastic proper-
chemical bonding (nanolayering) between the calci- ties, and stiffness of the restorative material, but
um and phosphate groups in the adhesive. Similar also on the individual treatment conditions, such as
immediate dentin bond strength results are shown cavity size and geometry, restorative placement, and
when etch-and-rinse and self-etch approaches are curing techniques.56 Another factor is the method of
compared.50 However, the bonding ability of Futur- resin composite application in the cavity. In this
abond U in the etch-and-rinse mode was significant- specific case, the resin composite was used in
ly lower after water storage compared with Futur- capsules, and applied directly to the cavity and not
abond U applied in the self-etch mode.50 Although in syringes as in previous studies.23-30 The use of
de Albuquerque & Others: Dual-cure Universal Simplified Adhesive—18-month Trial E267

capsules decreases the presence of voids and poros- groups. However, it is worth mentioning that all
ities in the final restorations.57,58 To the best of our marginal defects observed in the present study were
knowledge, the effects of inserting resin composites considered clinically acceptable and easily corrected
in capsules or syringes on the clinical performance of by the clinician through a repolish of the restora-
the composite resin restorations are not known. tions.63 Future long-term clinical follow-up studies
Future clinical studies need to be done to evaluate are still necessary to prove the results obtained in
the effect of inserting the resin composite in syringe this study.

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versus capsule in the clinical performance of NCCL Finally, this clinical study had some limitations.
restorations. The study was conducted in a university setting,
It is worth mentioning that the percentage of with all restorations placed in an ideal scenario by
marginal defects observed in several clinical studies four well-calibrated and supervised operators. In
that evaluated universal adhesives in NCCLs was this setting, only motivated patients with a low
still lower than in the present study.30,59 This could caries risk were included. Therefore, future clinical
be explained by the criteria used to evaluate the studies need to evaluate the universal adhesives in a
restorations. Although in the present study, FDI practice-based study, preferably in patients with
criteria were applied, the restorations were evaluat- high caries risk. Also, 18 months of clinical evalua-
ed using a modified USPHS criteria in the other tion could be considered a medium-term follow-up.
studies.30,59 In a recent literature review,60 it was Therefore, future long-term follow-up studies need to
shown that the use of FDI criteria for the clinical be done. However, the fact that Futurabond U
evaluation of direct restorations was more sensitive belongs to a very versatile and moisture tolerant
and precise in detecting minor failure compared with universal adhesive category warranted this medium-
modified USPHS criteria.23,24,26,27,49 A few restora- term evaluation.
tions were observed with marginal adaptation
problems when evaluated by USPHS criteria in the CONCLUSION
present study as well as in results of previous studies
After 18 months in NCCLs, the clinical performance
evaluating NCCL adhesive restorations with the
of Futurabond U was very good when used in the
same criteria.23,24,30,59
etch-and-rinse technique and maintaining dentin
The use of selective etching of the enamel margins moisture or slightly drying the dentin. The clinical
has been recommended prior to the application of performance was also very good when Futurabond U
self-etch adhesives to overcome this limitation.61,62 was used in the self-etch mode associated with
However, note that the results of the present study selective enamel etching, although more marginal
showed no significant difference in the marginal discrepancy was observed in the self-etch mode.
adaptation when the SEE and SET groups were
compared using USPHS and FDI criteria. This could
Acknowledgements
be attributed to the low number of restorations with
This project was supported by the National Council for
marginal defects, as previously described. Scientific and Technological Development (CNPq) under grants
On the other hand, when SQUACE was applied,37 305588/2014-1 and 303332/2017-4 and in part by the Coor-
denação de Aperfeiçoamento de Pessoal de Nı́vel Superior -
some differences were observed between SEE and Brasil (CAPES) - Finance Code 001.
SET. Although SQUACE, in addition to the FDI
criteria, has been proposed to improve the marginal Regulatory Statement
quality evaluation,37 only a few clinical trials have
This study was conducted in accordance with all the
used this auxiliary method.23,24,26 Perdigão and provisions of the local human subjects oversight committee
others23 showed that, when SQUACE was used, guidelines and policies of the Federal University Fluminense,
SEE resulted in a significantly greater number of Campus Nova Friburgo and State University of Ponta Grossa.
The approval codes issued for this study are 165.357/2016 and
restorations, between 10% and 30% of the total 1.618.895/2016.
length of the interface, showing a marginal discrep-
ancy compared with the SET group or even com- Conflict of Interest
pared with the ERWet and ERDry groups. The authors of this manuscript certify that they have no
In the present study, when SQUACE was used, proprietary, financial, or other personal interest of any nature
or kind in any product, service, and/or company that is
this same pattern was observed, as the SEE group presented in this article.
showed a statistical difference at the 18-month
recall rate compared with the other experimental (Accepted 23 October 2019)
E268 Operative Dentistry

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