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Review
Article history: Objectives: To establish whether simplified adhesives (self-etch) are as clinically effective as
Received 1 November 2011 conventional adhesives (etch-and-rinse) with multiple application steps for treatment of
Received in revised form non-carious cervical lesions (NCCLs).
4 February 2012 Null hypothesis: there is no difference in the clinical effectiveness of the four different
Accepted 10 February 2012 bonding strategies: Three-step etch-and-rinse; Two-step etch-and-rinse; Two-step self-
etch; One-step self-etch for treatment of NCCLs.
Sources: Electronic databases were searched including: Cochrane Oral Health Group Trials
Keywords: Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and
Adhesives EMBASE. In addition, studies were identified by handsearching of selected journals.
Systematic review Study selection: Randomised controlled trials (RCTs) comparing at least two adhesives in
Non-carious cervical lesions non-carious cervical lesions (NCCLs), with at least 18 months follow-up were selected. The
Clinical effectiveness primary outcome was loss of retention/restoration loss, with marginal adaptation and
marginal discolouration as secondary outcomes. Criteria for quality assessment included:
random sequence generation; allocation concealment; blinding of outcome assessment;
and information on withdrawals. Twenty six studies were identified that met the inclusion
criteria. In general, studies were not of sufficient quality to fully address the objectives of
this review.
Conclusion: There is not enough evidence to support one adhesive or bonding strategy over
another for treatment of NCCLs. Consequently, the null hypothesis of no difference cannot
be supported or rejected with the data currently available. There is a need for better
standardisation and reporting of randomised controlled trials investigating adhesive per-
formance.
Clinical significance: Studies with low overall risk of bias demonstrated good clinical perfor-
mance for adhesives with all four bonding strategies. However, included studies showed
wide variation between adhesives of the same category.
# 2012 Elsevier Ltd. All rights reserved.
* Corresponding author at: Colgate Australian Clinical Dental Research Centre, 2nd Floor, Adelaide Dental Hospital, Frome Road, Adelaide,
SA 5001, Australia. Tel.: +61 8 8303 3436.
E-mail address: brian.chee@adelaide.edu.au (B. Chee).
0300-5712/$ – see front matter # 2012 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jdent.2012.02.007
444 journal of dentistry 40 (2012) 443–452
1. Introduction reports of the same study were combined to make one entry.
Included studies had a minimum follow-up period of
Direct resin composite restorations are commonplace in 18 months and compared at least two adhesive systems.
dentistry and can provide predictable tooth-coloured restora- The primary outcome was loss of retention. Secondary
tions.1,2 However, their success is reliant upon adhesion to the outcomes were marginal integrity and marginal discoloura-
underlying tooth via adhesive systems, which in turn facilitate a tion.
more conservative approach to cavity preparation, less reliant Studies were considered for inclusion if they evaluated
on the traditional removal of tooth structure for mechanical resin-based adhesive systems used in conjunction with direct
retention and resistance form. The mechanism of adhesion is composite resin. Adhesives were categorised according to the
essentially micromechanical to etched enamel or via the classification described by Van Meerbeek et al.13 This
formation of a hybrid layer with dentine.3,4 This conventionally systematic review only evaluated adhesive systems with the
involves etching the tooth with 30–40% phosphoric acid, following bonding strategies:
followed by the application of a primer and subsequently an
adhesive resin: the 3-step etch-and-rinse approach. 1. Three-step etch-and-rinse
The efficacy of three-step etch-and-rinse systems is well 2. Two-step etch-and-rinse
established.5,6 However, many clinicians perceive these three- 3. Two-step self-etch
step systems to have high technique sensitivity. A desire to 4. One-step self-etch
reduce technique sensitivity and clinical time has led manu-
facturers to develop simplified systems. Two-step etch-and- Eligible studies included participants who were healthy
rinse systems combine the primer and adhesive into one bottle adults in any age group (male and female) with NCCLs in the
but maintain a separate etching step to remove the smear layer permanent dentition. All settings were included (academic
and demineralise the surface layer of enamel and dentine. Self- university department, dental hospital, primary care, private
etch systems penetrate through the smear layer and incorporate practice).
it into the hybrid layer to varying degrees dependent upon their Studies were excluded if:
acidity. They consist of either a self-etching primer accompanied
by an adhesive resin applied as a subsequent step, or a self-etch Carious cervical lesions were treated.
adhesive which does not require a separate primer. However, Other types of cavity were treated other than class V.
concerns have been raised regarding the bonding performance Lesions had undercuts or were prepared with mechanical
and durability of some simplified systems.7 retention.
Although the role of in vitro data to predict clinical The adhesive was not used according to the instructions of
performance is increasingly recognised,8,9 randomised con- the manufacturer.
trolled trials (RCTs) remain the most rigorous study design for The follow-up period was less than 18 months.
assessing the clinical effectiveness of an intervention. The Studies had extremely low recall rates (<75% after
majority of studies investigating the clinical effectiveness of 18 months, <60% after 3 years and <50% after 5 years or
bonding systems use the longevity of restorations in non- more).
carious cervical lesions (NCCLs) as the outcome. These lesions There was no appropriate control group (either another
are considered advantageous in the assessment of adhesive resin-based adhesive or resin modified glass ionomer
systems.10 Amongst other benefits, they offer no mechanical cement).
retention form and are located mainly in dentine, facilitating A bonding strategy was used other than those outlined
evaluation of the resin–dentine bond which is less stable than above.
the resin–enamel bond. Previous systematic reviews9,11,12 have
investigated the clinical effectiveness of adhesives, although To identify trials to be included for this review, a search
detailed methods of quality assessment and a transparent strategy developed for MEDLINE (via OVID) was revised
search protocol are not always available. appropriately for each database used (Table 1). The search
This study aims to evaluate the clinical effectiveness of protocol incorporated the Cochrane Highly Sensitive Search
contemporary resin-based adhesive systems by systematic Strategy for identifying reports of randomised controlled
review of the literature from 1950 to 2011. The specific trials.14 No language restrictions were applied.
objective is to compare the various bonding strategies in the The following electronic databases were searched on 8th
restoration of NCCLs. The primary outcome of restoration August 2011:
retention and the secondary outcomes of marginal integrity
and discolouration are employed to establish whether self-
etch adhesives are as clinically effective as etch-and-rinse Cochrane Oral Health Group Trials Register
systems. The null hypothesis for this study was that no Cochrane Central Register of Controlled Trials (CENTRAL)
differences would be detected between each adhesive type. via the Cochrane Library, to current issue
MEDLINE via OVID (1950–August 2011)
EMBASE via OVID (1980–August 2011)
2. Materials and methods
The reference lists of other systematic reviews and
RCTs that evaluated the clinical effectiveness of adhesives in identified trials were searched for additional relevant studies.
NCCLs were included in this systematic review. Multiple Conference abstracts were not included unless a full report of
journal of dentistry 40 (2012) 443–452 445
Table 1 – Search strategy for Medline (OVID). year of publication. Data were extracted using customised
Search strategy 8/8/11 extraction forms and the following data recorded for each
1. non-carious.mp. included study:
2. class V.mp.
3. cervical.mp. Details of the study including year of publication and
4. or/1–3
author(s).
5. lesion$.mp.
6. restoration$.mp.
Details of study methods including follow-up period,
7. composite.mp. sequence generation, allocation concealment and blinding.
8. cavity.mp. Details of participants including age, gender, setting and the
9. cavities.mp. inclusion criteria of the trial.
10. or/5–9 Details of the adhesives and composite resins used,
11. dental bonding/
including restorative protocol (cavity preparation, enamel
12. dentine-bonding agents/
bevelling, methods of isolation, and methods of polymeri-
13. bonding agent$.mp.
14. dentine$ bonding agent$.mp. sation).
15. adhesive$.mp. or adhesives/ Details of the outcomes including loss of retention, marginal
16. composite resin$.mp. or Composite Resins/ integrity, marginal discolouration, secondary caries, num-
17. (generation and (fourth or 4th or fifth or 5th or sixth ber of drop-outs and statistical analysis
or 6th or seventh or 7th)).mp.
18. (step and (three or ‘3’ or two or ‘2’ or one or single or ‘1’)).mp.
The quality of each included study was assessed in
19. ((‘etch and rinse’) or ‘etch & rinse’ or ‘self etch’
duplicate by two independent reviewers (BC and JS). Any
or ‘self-etch’ or ‘one bottle’ or ‘one-bottle’
or ‘all in one’ or ‘all-in-one’).mp. disagreement was resolved by discussion and if necessary by
20. or/11–19 referral to a third reviewer (LR).
21. randomized controlled trial.pt. The key criteria for judging risk of bias included the
22. controlled clinical trials.pt. following:
23. randomized.ab.
24. randomised.ab.
Random sequence generation
25. randomly.ab.
26. trial.ab.
Allocation concealment
27. groups.ab. Blinding of outcome assessment
28. ‘split-mouth’.mp. Incomplete outcome data including excluded data and drop-
29. or/21–28 outs
30. exp animals/ not humans.sh. Selective outcome reporting
31. 29 not 30
32. 4 and 10 and 20 and 29 and 31
The quality assessment was pilot tested using a sample of
study reports to ensure that the criteria were applied
eligible studies could be obtained. Manufacturers of adhesive consistently. For each aspect of the quality assessment, the
systems and selected study authors were contacted to identify risk of bias was scored following recommendations as
unpublished and ongoing trials. described in the Cochrane Handbook for Systematic reviews of
The following journals known to publish clinical trials on Interventions 5.0.2. The judgement for each entry involved
adhesives were identified: recording ‘yes’ indicating low risk of bias, ‘no’ indicating high
risk of bias, and ‘unclear’ indicating either lack of information
Acta Odontologica Scandinavica or uncertainty over the potential for bias.
British Dental Journal Studies were considered to be at low risk of bias if there was
Dental Materials adequate sequence generation, blinded outcome assessment
Journal of Adhesive Dentistry and adequate information on withdrawals. If one or more of
Journal of the American Dental Association (JADA) these criteria were not met a study would be considered at
Journal of Dental Research moderate or high risk of bias, respectively.
Journal of Dentistry The extracted data were analysed using Revman 5 (Review
Journal of Prosthetic Dentistry Manager ver. 5, The Cochrane Collaboration, Copenhagen,
Operative Dentistry Denmark) and reported according to Cochrane Collaboration
criteria14 and PRISMA guidelines.15 Data from eligible studies
Journals not already handsearched by the Cochrane Oral were either dichotomous (loss of retention, occurrence of
Health Group handsearching program were handsearched by secondary caries) or ordinal (marginal adaptation and mar-
one reviewer. Electronic searches were screened by one ginal discolouration). Ordinal data (mostly modified USPHS
reviewer to identify eligible studies. Full text versions of the criteria)16 were dichotomised into either ‘clinically acceptable’
papers that appeared to meet the inclusion criteria were or ‘clinically unacceptable’, i.e. alpha and bravo scores were
retrieved for further assessment and data extraction. Full categorised as clinically acceptable, while charlie scores or
reports were also obtained when there was insufficient lower were considered clinically unacceptable.
information in the title and abstract to make a clear decision. Comparisons were made between adhesive systems and
To aid the management of a large number of studies, each between the four types of bonding strategy. The following data
eligible study was given a study ID, combining first author and syntheses were planned if available data allowed:
446 journal of dentistry 40 (2012) 443–452
Table 2 – Characteristics of excluded studies. from the report or retrieved by the author were not included in
Reason for exclusion Number of the data synthesis.
excluded papers Trials were assessed for clinical heterogeneity. If they were
similar (in terms of participants, interventions and outcomes
Randomised allocation not reported 11
Less than 18 months follow-up period 23 measured) formal assessment of heterogeneity was planned
Lack of adequate control 23 using chi-squared test and I2 statistic. Subgroup analysis was
Manufacturers instructions not followed 3 carried out to examine the effect of follow-up period and risk
Cavities other than NCCL used 9 of bias on the results.
Low recall rate 2
Adhesive(s) investigated were 6
not contemporary 3. Results
Total 77
447
448 journal of dentistry 40 (2012) 443–452
Table 4 – Marginal discolouration: clinically acceptable Table 5 – Marginal integrity: clinically acceptable re-
restorations (%) for adhesive type across studies. storations (%) for adhesive type across studies.
Reported percentages (%) Reported percentages (%)
3-Step etch-and-rinse 3-Step etch-and-rinse
Clearfil Liner Bond II 10035, 10039 Clearfil Liner Bond II 9139, 10035
Optibond FL 946, 10020 Optibond FL 1006, 10020
Permaquick 946, 976 Permaquick 1006, 1006
Scotch-Bond Multi-Purpose 8733, 90(a)26, 10022, 10034, 10037 Scotch-Bond Multi-Purpose 73(a)26, 9633, 10022, 10034, 10037
Imperva Bond 9240 Imperva Bond 9240
EBS 10038 EBS 9038
Allbond 3 10031 Allbond 3 10031
GLUMA Solid Bond 100(a)28 GLUMA Solid Bond 92(a)28
2-Step etch-and-rinse 2-Step etch-and-rinse
One Coat Bond 8633, 10039 One Coat Bond 8739, 8833
One-step 10018, 10029, 10038 One-Step 5138, 10018, 10029
Prime & Bond 2.1 94(a)23, 10021 Prime & Bond 2.1 9521, 100(a)23
Prime & Bond NT 10024 Prime & Bond NT 10024
Single Bond 83(a)27, 9533, 10017, 10035, 10029 Single Bond 83(a)27, 9533, 9735, 10017, 10029
Optibond Solo 91(a)23 Optibond Solo 91(a)23
Excite 10032 Excite 9732
2-Step self-etch 2-Step self-etch
Tyrian 10018 Tyrian 10018
Allbond SE 10030 Allbond SE 10030
Prisma Universal Bond 3 10040 Prisma Universal Bond 3 10040
Clearfil SE Bond 10019, 10024, 10044 Clearfil SE Bond 7644, 10019, 10024
1-Step self-etch 1-Step self-etch
G-Bond 10020, 10036 G-Bond 10036, 10020
S3 Bond 10019, 10036 S3 Bond 10019, 10036
Adper Prompt 53(a)27, 10034 Adper Prompt 67(a)27, 10034
Prompt L-Pop 10039 Prompt-L-Pop 7939
iBond 35(a)28, 69(a)28 iBond 70(a)28, 81(a)28
(a) = percentage alpha scores reported. (a) = percentage alpha scores reported.
they can be used with or without the application of a separate ment was not reported in any of the included studies and 58%
bonding resin layer, although the manufacturer recommends reported blind evaluation. In 62% of the included studies,
its application for improved performance. The majority of information was provided on participants/restorations not
studies reported cleaning of NCCLs with pumice and water available at follow-up, with the reasons given. Eighty one
prior to bonding. Variation in clinical technique was noted, percent of studies were free of selective reporting, but only
with 10 studies isolating with rubber dam6,21,25–32 and the seven out of 26 studies (27%) were free of other bias. The most
remaining studies isolating with a combination of cotton rolls, common reasons for this were either a lack of operator/
saliva ejector and retraction cord or other retraction instru- assessor calibration or failure to account for clustering within
ments. Ten of the included studies prepared the NCCLs with participants. Summaries of the overall risk of bias are
an enamel bevel,6,20,23,26,28,33–37 and ten of the studies prepared presented graphically in Figs. 2 and 3. For the primary
dentine by bur roughening.20,22–24,28,34–36,38,39 Some studies outcome, only five studies were considered to have low risk
investigated materials in addition to resin-based adhesives, of bias for all key domains.6,20,29–31
including resin-modified glass ionomer cement The worst clinical performance reported in terms of
(RMGIC)17,22,37,38,40 and poly-acid modified composite resins marginal integrity was found for One-Step with 51% of
(compomers).22,25 Data for these materials were not used in restorations considered clinically acceptable at 36 months.38
this review, although resin-modified glass ionomers were
considered an appropriate control group.
Most studies used modified USPHS criteria with two studies
using very similar Vanherle criteria.6,20 The duration of the
studies varied from 18 months to 8 years. Data for the primary
outcome were presented as numbers of restorations lost, as
well as retention rates or cumulative failure rates (%).
Reporting of the secondary outcomes varied, but data could
be dichotomised into ‘clinically acceptable’ or ‘clinically
unacceptable’ except for five studies23,25–28 (Tables 4 and 5).
Cohen’s kappa coefficient was calculated for measuring
agreement between reviewers (BC, JS) and was considered Fig. 2 – Methodological quality graph: judgements about
‘excellent’ (0.88). Overall, only 23% of included studies clearly each methodological quality item presented as
described adequate sequence generation. Allocation conceal- percentages across all included studies.
journal of dentistry 40 (2012) 443–452 449
4. Discussion
should be caution if using this data in meta-analyses, as 4.4. Implication for research
uncorrected unit of analysis errors would cause the data to
receive too much weighting. This review has highlighted the need for better design,
implementation and reporting of RCTs. To facilitate meta-
4.2. Overall completeness and applicability of the evidence analysis studies should follow the CONSORT guidelines43 and
reports should include failure as the numbers of restorations
Risk of bias was mostly assessed at the outcome level, since lost. New adhesives should continue to be compared against
the criteria have different relevance to primary and secondary an established three-step etch-and-rinse adhesive, since they
outcomes, i.e. the blinding of outcome evaluation is less are supported by the most long-term clinical and laboratory-
important for restoration retention, as this outcome is very based evidence.8
objective. In contrast, inadequate blinding of outcome
assessment has greater risk of introducing bias in the more 4.5. Implications for practice
subjective outcomes (marginal integrity, marginal discoloura-
tion). It should be noted that a potential source of bias in a The included studies with low overall risks of bias6,20,29–31
systematic review investigating restoration longevity is that reported favourable medium-term (2–3 years) clinical perfor-
the USPHS criteria may not be consistently applied between mance for all four bonding strategies in terms of restoration
studies.42 retention. Optibond FL also showed excellent long-term
The most objective outcome to assess the clinical effec- performance with retention rates of 96% and 92%, respective-
tiveness of adhesive systems is retention of the class V ly, at 3 and 7 years.6,20 In these studies, five currently available
composite restoration, since bond failure will cause loss of the adhesives (Allbond 3, Allbond SE, G-Bond, Optibond FL,
restoration (in the absence of mechanical retention features). Permaquick) exceeded the performance needed for accep-
In this study, the inclusion of marginal discolouration and tance by the now discontinued ADA standards.41 The included
marginal integrity as outcomes measures is also essential, studies found wide variation between the clinical perfor-
since the breakdown of restoration margins is a common mances of adhesives with the same bonding strategy.
reason for the replacement and repair of adhesive restora-
tions.13
Blinding of the clinician is unfeasible in most trials that test 5. Conclusion
adhesives, as the specific clinical protocol needs to be known
for each adhesive and is difficult to conceal. Blinding of the There was insufficient evidence to make firm recommenda-
participant was explicitly described in only seven stud- tions for the use of one adhesive system or bonding strategy
ies.20,22,27,29–31,33 However, lack of patient blinding is unlikely over another. The proportion of information obtained from
to introduce bias as there were no patient-centred outcomes studies with an unclear or high risk of bias was high. The null
and their behaviour is unlikely to change as a result of hypothesis of no difference could not be supported or rejected
knowledge of the intervention groups. Sample size calcula- with the data currently available, using the robust analysis
tions were described by only four of the included stud- planned. Studies with low overall risk of bias found good
ies.23,27,30,31 Although trial authors and manufacturers were clinical performance for adhesives with three-step etch-and-
contacted to identify ongoing and unpublished trials, the rinse, two-step etch-and-rinse, two-step self-etch and one-
response was poor and none of the included studies were step self-etch bonding strategies.6,20,29–31 There is a need for
identified by this method. future research on the clinical effectiveness of adhesives. In
particular, better standardisation and reporting of randomised
4.3. Agreement and disagreement with other research controlled trials will allow more meaningful comparisons to
be made between adhesives.
The conclusions of other systematic reviews that investi-
gate the clinical performance of adhesives could not be
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