Review

Adhesives for the restoration of non-carious

cervical lesions: A systematic review
Brian Chee
a,
*, Luke J. Rickman
b
, Julian D. Satterthwaite
c
a
Clinical Teaching Fellow in Fixed and Removable Prosthodontics, School of Dentistry, University of Manchester, Higher Cambridge Street,
Manchester M15 6FH, United Kingdom
b
General Dental Practitioner, Antley Villa Dental Practice, 432 Blackburn Road, Accrington, Lancashire BB5 0DE, United Kingdom
c
Restorative Dentistry, School of Dentistry, University of Manchester, Higher Cambridge Street, Manchester M15 6FH, United Kingdom
j o ur na l o f d e nt i s t r y 4 0 ( 2 0 1 2 ) 4 4 3 4 5 2
a r t i c l e i n f o
Article history:
Received 1 November 2011
Received in revised form
4 February 2012
Accepted 10 February 2012
Keywords:
Adhesives
Systematic review
Non-carious cervical lesions
Clinical effectiveness
a b s t r a c t
Objectives: To establish whether simplied adhesives (self-etch) are as clinically effective as
conventional adhesives (etch-and-rinse) with multiple application steps for treatment of
non-carious cervical lesions (NCCLs).
Null hypothesis: there is no difference in the clinical effectiveness of the four different
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
Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and
EMBASE. In addition, studies were identied by handsearching of selected journals.
Study selection: Randomised controlled trials (RCTs) comparing at least two adhesives in
non-carious cervical lesions (NCCLs), with at least 18 months follow-up were selected. The
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 identied that met the inclusion
criteria. In general, studies were not of sufcient 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 signicance: 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).
Available online at www.sciencedirect.com
journal homepage: www.intl.elsevierhealth.com/journals/jden
0300-5712/$ see front matter # 2012 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jdent.2012.02.007
1. Introduction
Direct resin composite restorations are commonplace in
dentistry and can provide predictable tooth-coloured restora-
tions.
1,2
However, their success is reliant upon adhesion to the
underlying tooth via adhesive systems, which in turn facilitate a
more conservative approach to cavity preparation, less reliant
on the traditional removal of tooth structure for mechanical
retention and resistance form. The mechanism of adhesion is
essentially micromechanical to etched enamel or via the
formation of a hybrid layer with dentine.
3,4
This conventionally
involves etching the tooth with 3040% phosphoric acid,
followed by the application of a primer and subsequently an
adhesive resin: the 3-step etch-and-rinse approach.
The efcacy of three-step etch-and-rinse systems is well
established.
5,6
However, many clinicians perceive these three-
step systems to have high technique sensitivity. A desire to
reduce technique sensitivity and clinical time has led manu-
facturers to develop simplied systems. Two-step etch-and-
rinse systems combine the primer and adhesive into one bottle
but maintain a separate etching step to remove the smear layer
and demineralise the surface layer of enamel and dentine. Self-
etchsystems penetrate throughthe smear layer and incorporate
it into the hybrid layer to varying degrees dependent upon their
acidity. Theyconsist of either a self-etching primer accompanied
by an adhesive resin applied as a subsequent step, or a self-etch
adhesive which does not require a separate primer. However,
concerns have been raised regarding the bonding performance
and durability of some simplied systems.
7
Although the role of in vitro data to predict clinical
performance is increasingly recognised,
8,9
randomised con-
trolled trials (RCTs) remain the most rigorous study design for
assessing the clinical effectiveness of an intervention. The
majority of studies investigating the clinical effectiveness of
bonding systems use the longevity of restorations in non-
carious cervical lesions (NCCLs) as the outcome. These lesions
are considered advantageous in the assessment of adhesive
systems.
10
Amongst other benets, they offer no mechanical
retention form and are located mainly in dentine, facilitating
evaluation of the resindentine bond which is less stable than
the resinenamel bond. Previous systematic reviews
9,11,12
have
investigated the clinical effectiveness of adhesives, although
detailed methods of quality assessment and a transparent
search protocol are not always available.
This study aims to evaluate the clinical effectiveness of
contemporary resin-based adhesive systems by systematic
review of the literature from 1950 to 2011. The specic
objective is to compare the various bonding strategies in the
restoration of NCCLs. The primary outcome of restoration
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
systems. The null hypothesis for this study was that no
differences would be detected between each adhesive type.
2. Materials and methods
RCTs that evaluated the clinical effectiveness of adhesives in
NCCLs were included in this systematic review. Multiple
reports of the same study were combined to make one entry.
Included studies had a minimum follow-up period of
18 months and compared at least two adhesive systems.
The primary outcome was loss of retention. Secondary
outcomes were marginal integrity and marginal discoloura-
tion.
Studies were considered for inclusion if they evaluated
resin-based adhesive systems used in conjunction with direct
composite resin. Adhesives were categorised according to the
classication described by Van Meerbeek et al.
13
This
systematic review only evaluated adhesive systems with the
following bonding strategies:
1. Three-step etch-and-rinse
2. Two-step etch-and-rinse
3. Two-step self-etch
4. One-step self-etch
Eligible studies included participants who were healthy
adults in any age group (male and female) with NCCLs in the
permanent dentition. All settings were included (academic
university department, dental hospital, primary care, private
practice).
Studies were excluded if:
Carious cervical lesions were treated.
Other types of cavity were treated other than class V.
Lesions had undercuts or were prepared with mechanical
retention.
The adhesive was not used according to the instructions of
the manufacturer.
The follow-up period was less than 18 months.
Studies had extremely low recall rates (<75% after
18 months, <60% after 3 years and <50% after 5 years or
more).
There was no appropriate control group (either another
resin-based adhesive or resin modied glass ionomer
cement).
A bonding strategy was used other than those outlined
above.
To identify trials to be included for this review, a search
strategy developed for MEDLINE (via OVID) was revised
appropriately for each database used (Table 1). The search
protocol incorporated the Cochrane Highly Sensitive Search
Strategy for identifying reports of randomised controlled
trials.
14
No language restrictions were applied.
The following electronic databases were searched on 8th
August 2011:
Cochrane Oral Health Group Trials Register
Cochrane Central Register of Controlled Trials (CENTRAL)
via the Cochrane Library, to current issue
MEDLINE via OVID (1950August 2011)
EMBASE via OVID (1980August 2011)
The reference lists of other systematic reviews and
identied trials were searched for additional relevant studies.
Conference abstracts were not included unless a full report of
j our na l of d e nt i s t r y 4 0 ( 2 0 1 2 ) 4 4 3 4 5 2 444
eligible studies could be obtained. Manufacturers of adhesive
systems and selected study authors were contacted to identify
unpublished and ongoing trials.
The following journals known to publish clinical trials on
adhesives were identied:
Acta Odontologica Scandinavica
British Dental Journal
Dental Materials
Journal of Adhesive Dentistry
Journal of the American Dental Association (JADA)
Journal of Dental Research
Journal of Dentistry
Journal of Prosthetic Dentistry
Operative Dentistry
Journals not already handsearched by the Cochrane Oral
Health Group handsearching program were handsearched by
one reviewer. Electronic searches were screened by one
reviewer to identify eligible studies. Full text versions of the
papers that appeared to meet the inclusion criteria were
retrieved for further assessment and data extraction. Full
reports were also obtained when there was insufcient
information in the title and abstract to make a clear decision.
To aid the management of a large number of studies, each
eligible study was given a study ID, combining rst author and
year of publication. Data were extracted using customised
extraction forms and the following data recorded for each
included study:
Details of the study including year of publication and
author(s).
Details of study methods including follow-up period,
sequence generation, allocation concealment and blinding.
Details of participants including age, gender, setting and the
inclusion criteria of the trial.
Details of the adhesives and composite resins used,
including restorative protocol (cavity preparation, enamel
bevelling, methods of isolation, and methods of polymeri-
sation).
Details of the outcomes including loss of retention, marginal
integrity, marginal discolouration, secondary caries, num-
ber of drop-outs and statistical analysis
The quality of each included study was assessed in
duplicate by two independent reviewers (BC and JS). Any
disagreement was resolved by discussion and if necessary by
referral to a third reviewer (LR).
The key criteria for judging risk of bias included the
following:
Random sequence generation
Allocation concealment
Blinding of outcome assessment
Incomplete outcome data including excluded data and drop-
outs
Selective outcome reporting
The quality assessment was pilot tested using a sample of
study reports to ensure that the criteria were applied
consistently. For each aspect of the quality assessment, the
risk of bias was scored following recommendations as
described in the Cochrane Handbook for Systematic reviews of
Interventions 5.0.2. The judgement for each entry involved
recording yes indicating low risk of bias, no indicating high
risk of bias, and unclear indicating either lack of information
or uncertainty over the potential for bias.
Studies were considered to be at low risk of bias if there was
adequate sequence generation, blinded outcome assessment
and adequate information on withdrawals. If one or more of
these criteria were not met a study would be considered at
moderate or high risk of bias, respectively.
The extracted data were analysed using Revman 5 (Review
Manager ver. 5, The Cochrane Collaboration, Copenhagen,
Denmark) and reported according to Cochrane Collaboration
criteria
14
and PRISMA guidelines.
15
Data from eligible studies
were either dichotomous (loss of retention, occurrence of
secondary caries) or ordinal (marginal adaptation and mar-
ginal discolouration). Ordinal data (mostly modied USPHS
criteria)
16
were dichotomised into either clinically acceptable
or clinically unacceptable, i.e. alpha and bravo scores were
categorised as clinically acceptable, while charlie scores or
lower were considered clinically unacceptable.
Comparisons were made between adhesive systems and
between the four types of bonding strategy. The following data
syntheses were planned if available data allowed:
Table 1 Search strategy for Medline (OVID).
Search strategy 8/8/11
1. non-carious.mp.
2. class V.mp.
3. cervical.mp.
4. or/13
5. lesion$.mp.
6. restoration$.mp.
7. composite.mp.
8. cavity.mp.
9. cavities.mp.
10. or/59
11. dental bonding/
12. dentine-bonding agents/
13. bonding agent$.mp.
14. dentine$ bonding agent$.mp.
15. adhesive$.mp. or adhesives/
16. composite resin$.mp. or Composite Resins/
17. (generation and (fourth or 4th or fth or 5th or sixth
or 6th or seventh or 7th)).mp.
18. (step and (three or 3 or two or 2 or one or single or 1)).mp.
19. ((etch and rinse) or etch & rinse or self etch
or self-etch or one bottle or one-bottle
or all in one or all-in-one).mp.
20. or/1119
21. randomized controlled trial.pt.
22. controlled clinical trials.pt.
23. randomized.ab.
24. randomised.ab.
25. randomly.ab.
26. trial.ab.
27. groups.ab.
28. split-mouth.mp.
29. or/2128
30. exp animals/ not humans.sh.
31. 29 not 30
32. 4 and 10 and 20 and 29 and 31
j o ur na l o f d e nt i s t r y 4 0 ( 2 0 1 2 ) 4 4 3 4 5 2 445
For each trial risk ratios (RR) and their 95% condence
intervals calculated for dichotomous data (primary and
secondary outcomes).
Number of lesions needed to treat (NNT) to prevent loss of
retention in one class V restoration.
If appropriate, meta-analysis was planned by pooling the
risk ratios of the individual trials using a random-effects
model in cases where there were three or more trials. If
fewer trials were included for a comparison, then the xed
effects model would be used.
Following the data extraction and quality assessment
process, trial authors were contacted in order to obtain
further information of any unclear or missing data. Included
studies for which the necessary data could not be extracted
from the report or retrieved by the author were not included in
the data synthesis.
Trials were assessed for clinical heterogeneity. If they were
similar (in terms of participants, interventions and outcomes
measured) formal assessment of heterogeneity was planned
using chi-squared test and I
2
statistic. Subgroup analysis was
carried out to examine the effect of follow-up period and risk
of bias on the results.
3. Results
One hundred and three studies were identied. Following
assessment, 77 of these were excluded for the reasons listed in
Table 2. In the 26 studies identied for inclusion, 13 were
designed as parallel group studies, 11 had a paired design and
two had quadrant allocation. An overview of the number of
study reports screened, assessed and included in the review
can be seen in Fig. 1.
The majority of included studies reported university dental
hospitals as the research setting. The mean age of participants
across studies was 52.9 (SD 6.0), although this did not take into
account four studies where median age or age ranges were
reported,
1720
and three studies where age was not
reported.
6,21,22
All patients were adult and had NCCLs,
although Ritter et al.
23
and Turkun
24
both included two
lesions that had supercial areas of caries removed.
Details of adhesive systems used in the included trials can
be seen in Table 3. Allbond 3 and Allbond SE are of interest, as
Table 2 Characteristics of excluded studies.
Reason for exclusion Number of
excluded papers
Randomised allocation not reported 11
Less than 18 months follow-up period 23
Lack of adequate control 23
Manufacturers instructions not followed 3
Cavities other than NCCL used 9
Low recall rate 2
Adhesive(s) investigated were
not contemporary
6
Total 77
Records excluded
11
Full-text articles excluded,
with reasons
77
Studies included in quantitative
synthesis (meta-analysis)
0
Records identified through database
searching
719
Additional records identified
through other sources
3
Records screened
114
Full-text articles assessed for eligibility
103
Studies included in qualitative
synthesis
26
Records after duplicates removed
721
I
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a
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*
* records remaining after removal of non-relevant articles
E
l
i
g
i
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i
l
i
t
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e
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Fig. 1 Flow diagram of study identification.
15
j our na l of d e nt i s t r y 4 0 ( 2 0 1 2 ) 4 4 3 4 5 2 446
Table 3 Characteristics of included studies.
Study ID Study design Participants Restorations Recall
period
(months)
Mean age Dentine
prep
Enamel
bevel
Isolation Adhesive(s)
Aw et al.
33
Parallel group 57 171 18 51 N Y Retraction cord Scotch-Bond Multi-Purpose, Single
Bond, One Coat Bond
Brackett et al.
17
Paired design 24 74 24 47 N N Retraction cord Single Bond
Brackett et al.
18
Paired design 25 76 18 Median 52 N N Retraction cord Tyrian, One-Step
Brackett et al.
19
Paired design 14 80 24 Median 46 N N Retraction cord Clearl SE Bond, Clearl S3 Bond
Kim et al.
34
Parallel group 39 150 24 50 Y Y Retraction cord Scotch-Bond Multi-Purpose,
Adper Prompt
Kubo et al.
35
Quadrant 8 72 60 61.3 Y Y Retraction cord Clearl Liner Bond II, Single Bond
Kubo et al.
36
Quadrant 23 108 24 61.8 Y Y Retraction cord S3 Bond, G-Bond
Loguercio et al.
27
Paired design 25 78 36 Range reported N N Rubber dam Single Bond, Adper Prompt
Loguercio et al.
30
Paired design 33 66 24 Range reported N N Rubber dam All Bond SE (one-step), All Bond
SE (two-step)
Matis et al.
26
Paired design 30 80 36 45 N Y Rubber dam FL-Bond, Scotch-Bond Multi-Purpose
McCoy et al.
25
Parallel group 23 126 36 48 N N Rubber dam All-Bond 2, ART Bond, Prisma
Universal Bond 3
Merte et al.
21
Parallel group 80 89 24 ? N N Rubber dam Prime & Bond 2.1
Neo et al.
40
Parallel group 10 83 18 47 N N Retraction cord Prisma Universal Bond 3, Imperva Bond
Onal and Pamir
22
Parallel group 30 130 24 ? Y N Cotton rolls, suction Scotch-Bond Multi-Purpose
Ozgunaltay and Onen
37
Paired design 24 98 36 Range reported N Y Retraction cord Scotch-Bond Multi-Purpose
Peumans et al.
6
Paired design 71 142 84 ? N Y Rubber dam Permaquick, Optibond FL
Reis and Loguercio
29
Parallel group 84 84 36 Range reported N N Rubber dam Single Bond, One Step
Reis et al.
31
Paired design 33 66 24 Range reported N N Rubber dam All-Bond 3 (2-step), All-Bond 3 (3-step)
Ritter et al.
28
Parallel group 30 105 36 55 Y Y Rubber dam iBond, Gluma Solid Bond
Ritter et al.
23
Parallel group 33 99 96 53 Y Y Retraction cord Optibond Solo, Prime & Bond 2.1
Santiago et al.
32
Paired design 30 70 24 Range reported N N Rubber dam Excite
Turkun
24
Paired design 32 98 24 46 Y N Retraction cord Clearl SE Bond, Prime & Bond NT
Van Dijken
38
Parallel group 60 148 36 57 Y N Retraction instrument EBS, One-Step
Van Dijken
39
Parallel group 90 144 24 58 Y N Retraction instrument Clearl Liner Bond II, One Coat
Bond, Prompt L-pop
Van Dijken
44
Parallel group 72 119 96 60.1 N N Retraction instrument Clearl SE Bond, PQ1
Van Landuyt et al.
20
Parallel group 52 267 36 Range reported Y Y Retraction cord/matrix G-Bond, Optibond FL
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they can be used with or without the application of a separate
bonding resin layer, although the manufacturer recommends
its application for improved performance. The majority of
studies reported cleaning of NCCLs with pumice and water
prior to bonding. Variation in clinical technique was noted,
with 10 studies isolating with rubber dam
6,21,2532
and the
remaining studies isolating with a combination of cotton rolls,
saliva ejector and retraction cord or other retraction instru-
ments. Ten of the included studies prepared the NCCLs with
an enamel bevel,
6,20,23,26,28,3337
and ten of the studies prepared
dentine by bur roughening.
20,2224,28,3436,38,39
Some studies
investigated materials in addition to resin-based adhesives,
including resin-modied glass ionomer cement
(RMGIC)
17,22,37,38,40
and poly-acid modied composite resins
(compomers).
22,25
Data for these materials were not used in
this review, although resin-modied glass ionomers were
considered an appropriate control group.
Most studies used modied 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 ve studies
23,2528
(Tables 4 and 5).
Cohens kappa coefcient was calculated for measuring
agreement between reviewers (BC, JS) and was considered
excellent (0.88). Overall, only 23% of included studies clearly
described adequate sequence generation. Allocation conceal-
ment was not reported in any of the included studies and 58%
reported blind evaluation. In 62% of the included studies,
information was provided on participants/restorations not
available at follow-up, with the reasons given. Eighty one
percent of studies were free of selective reporting, but only
seven out of 26 studies (27%) were free of other bias. The most
common reasons for this were either a lack of operator/
assessor calibration or failure to account for clustering within
participants. Summaries of the overall risk of bias are
presented graphically in Figs. 2 and 3. For the primary
outcome, only ve studies were considered to have low risk
of bias for all key domains.
6,20,2931
The worst clinical performance reported in terms of
marginal integrity was found for One-Step with 51% of
restorations considered clinically acceptable at 36 months.
38
Table 4 Marginal discolouration: clinically acceptable
restorations (%) for adhesive type across studies.
Reported percentages (%)
3-Step etch-and-rinse
Clearl Liner Bond II 100
35
, 100
39
Optibond FL 94
6
, 100
20
Permaquick 94
6
, 97
6
Scotch-Bond Multi-Purpose 87
33
, 90(a)
26
, 100
22
, 100
34
, 100
37
Imperva Bond 92
40
EBS 100
38
Allbond 3 100
31
GLUMA Solid Bond 100(a)
28
2-Step etch-and-rinse
One Coat Bond 86
33
, 100
39
One-step 100
18
, 100
29
, 100
38
Prime & Bond 2.1 94(a)
23
, 100
21
Prime & Bond NT 100
24
Single Bond 83(a)
27
, 95
33
, 100
17
, 100
35
, 100
29
Optibond Solo 91(a)
23
Excite 100
32
2-Step self-etch
Tyrian 100
18
Allbond SE 100
30
Prisma Universal Bond 3 100
40
Clearl SE Bond 100
19
, 100
24
, 100
44
1-Step self-etch
G-Bond 100
20
, 100
36
S3 Bond 100
19
, 100
36
Adper Prompt 53(a)
27
, 100
34
Prompt L-Pop 100
39
iBond 35(a)
28
, 69(a)
28
(a) = percentage alpha scores reported.
Table 5 Marginal integrity: clinically acceptable re-
storations (%) for adhesive type across studies.
Reported percentages (%)
3-Step etch-and-rinse
Clearl Liner Bond II 91
39
, 100
35
Optibond FL 100
6
, 100
20
Permaquick 100
6
, 100
6
Scotch-Bond Multi-Purpose 73(a)
26
, 96
33
, 100
22
, 100
34
, 100
37
Imperva Bond 92
40
EBS 90
38
Allbond 3 100
31
GLUMA Solid Bond 92(a)
28
2-Step etch-and-rinse
One Coat Bond 87
39
, 88
33
One-Step 51
38
, 100
18
, 100
29
Prime & Bond 2.1 95
21
, 100(a)
23
Prime & Bond NT 100
24
Single Bond 83(a)
27
, 95
33
, 97
35
, 100
17
, 100
29
Optibond Solo 91(a)
23
Excite 97
32
2-Step self-etch
Tyrian 100
18
Allbond SE 100
30
Prisma Universal Bond 3 100
40
Clearl SE Bond 76
44
, 100
19
, 100
24
1-Step self-etch
G-Bond 100
36
, 100
20
S3 Bond 100
19
, 100
36
Adper Prompt 67(a)
27
, 100
34
Prompt-L-Pop 79
39
iBond 70(a)
28
, 81(a)
28
(a) = percentage alpha scores reported.
Fig. 2 Methodological quality graph: judgements about
each methodological quality item presented as
percentages across all included studies.
j our na l of d e nt i s t r y 4 0 ( 2 0 1 2 ) 4 4 3 4 5 2 448
However, Bracket et al. as well as Reis et al. found 100% clinical
acceptability for this adhesive at 18 and 36 months, respec-
tively.
18,29
One Coat Bond had the poorest reported clinical
performance in terms of marginal discolouration, with 86% of
restorations clinically acceptable at 18 months, although there
was no signicant difference between adhesives ( p > 0.05).
33
The percentages of clinically acceptable restorations in terms
of marginal discolouration and marginal integrity are sum-
marised for each adhesive system in Tables 4 and 5.
4. Discussion
4.1. Summary of main results
The studies included in this review evaluated 26 resin-based
adhesives and recruited 1032 participants. There was variation
in study methodology and quality, although several of the
designs were based on acceptance programme guidelines of
The American Dental Association, which have since been
discontinued.
41
The primary outcome was often presented as
retention rates or cumulative failure rates (%), calculated
according to the ADA recommended equation:
Failure percentage 100%
previous failures new failures
previous failures currently recalled restorations
Only ve studies were considered to have a low overall risk
of bias
6,20,2931
and the other studies were generally not of
sufcient quality to address the objectives of this review.
Frequently, data from studies were either reported inade-
quately or were inappropriate for use in meta-analyses.
Hence, this review was limited to the qualitative description
of studies. It should be noted that several excluded studies had
robust designs for their specic research question but did not
have an adequate control for the objectives of this systematic
review. For example, studies that investigated a single
adhesive under different conditions, or investigated a single
adhesive in conjunction with different resin composites had
no effective control regarding the adhesive system, and were
therefore excluded.
The planned analyses such as risk ratios, number needed to
treat and statistical heterogeneity (chi-squared test and I
2
statistic) were not possible with the available data. A large
proportion of the raw data required for the proposed analyses
was not reported or could not be extracted from reported
percentages. Trial authors were contacted to request the
original data, although there was a poor response. A number of
studies used the restoration as the unit of analysis, rather than
the patient and many studies had multiple restorations per
patient. Although the majority of studies controlled for the
effects of clustering by limiting the number of restorations per
patient (typically less than 3), few studies accounted for the
clustering in the statistical analysis and the fact that failure
events were not independent. It was not considered appropri-
ate to use data that did not take into account this clustering
within patients, as these units of analysis errors can produce
over-precise results and p-values that are too small.
14
Although it has been argued that including multiple restora-
tions per patient is a valid way of increasing sample size
provided that appropriate analyses are performed
8
there
Fig. 3 Methodological quality summary: judgements
about each methodological quality item for each study.
j o ur na l o f d e nt i s t r y 4 0 ( 2 0 1 2 ) 4 4 3 4 5 2 449
should be caution if using this data in meta-analyses, as
uncorrected unit of analysis errors would cause the data to
receive too much weighting.
4.2. Overall completeness and applicability of the evidence
Risk of bias was mostly assessed at the outcome level, since
the criteria have different relevance to primary and secondary
outcomes, i.e. the blinding of outcome evaluation is less
important for restoration retention, as this outcome is very
objective. In contrast, inadequate blinding of outcome
assessment has greater risk of introducing bias in the more
subjective outcomes (marginal integrity, marginal discoloura-
tion). It should be noted that a potential source of bias in a
systematic review investigating restoration longevity is that
the USPHS criteria may not be consistently applied between
studies.
42
The most objective outcome to assess the clinical effec-
tiveness of adhesive systems is retention of the class V
composite restoration, since bond failure will cause loss of the
restoration (in the absence of mechanical retention features).
In this study, the inclusion of marginal discolouration and
marginal integrity as outcomes measures is also essential,
since the breakdown of restoration margins is a common
reason for the replacement and repair of adhesive restora-
tions.
13
Blinding of the clinician is unfeasible in most trials that test
adhesives, as the specic clinical protocol needs to be known
for each adhesive and is difcult to conceal. Blinding of the
participant was explicitly described in only seven stud-
ies.
20,22,27,2931,33
However, lack of patient blinding is unlikely
to introduce bias as there were no patient-centred outcomes
and their behaviour is unlikely to change as a result of
knowledge of the intervention groups. Sample size calcula-
tions were described by only four of the included stud-
ies.
23,27,30,31
Although trial authors and manufacturers were
contacted to identify ongoing and unpublished trials, the
response was poor and none of the included studies were
identied by this method.
4.3. Agreement and disagreement with other research
The conclusions of other systematic reviews that investi-
gate the clinical performance of adhesives could not be
supported by this review. Peumans et al.
11
found less
favourable clinical performance in the self-etch bonding
strategies compared with an etch-and-rinse protocol.
Superior performance of etch-and-rinse systems was also
reported by Heintze et al.
9
in a systematic review of clinical
trials from 1994 to 2008. Krithikadatta
12
published a
systematic review addressing the same research question
including studies from 2004 to 2010 and concluded that the
clinical performance of different categories of bonding
system were comparable.
Not all the reviews above present full details regarding their
methodology and review/assessment process; however, the
different conclusions reached in these studies may be
explained by the rigorous selection criteria and robust quality
assessment applied in the present review, with only high
quality evidence being considered.
4.4. Implication for research
This review has highlighted the need for better design,
implementation and reporting of RCTs. To facilitate meta-
analysis studies should follow the CONSORT guidelines
43
and
reports should include failure as the numbers of restorations
lost. New adhesives should continue to be compared against
an established three-step etch-and-rinse adhesive, since they
are supported by the most long-term clinical and laboratory-
based evidence.
8
4.5. Implications for practice
The included studies with low overall risks of bias
6,20,2931
reported favourable medium-term (23 years) clinical perfor-
mance for all four bonding strategies in terms of restoration
retention. Optibond FL also showed excellent long-term
performance with retention rates of 96% and 92%, respective-
ly, at 3 and 7 years.
6,20
In these studies, ve currently available
adhesives (Allbond 3, Allbond SE, G-Bond, Optibond FL,
Permaquick) exceeded the performance needed for accep-
tance by the now discontinued ADA standards.
41
The included
studies found wide variation between the clinical perfor-
mances of adhesives with the same bonding strategy.
5. Conclusion
There was insufcient evidence to make rm recommenda-
tions for the use of one adhesive system or bonding strategy
over another. The proportion of information obtained from
studies with an unclear or high risk of bias was high. The null
hypothesis of no difference could not be supported or rejected
with the data currently available, using the robust analysis
planned. Studies with low overall risk of bias found good
clinical performance for adhesives with three-step etch-and-
rinse, two-step etch-and-rinse, two-step self-etch and one-
step self-etch bonding strategies.
6,20,2931
There is a need for
future research on the clinical effectiveness of adhesives. In
particular, better standardisation and reporting of randomised
controlled trials will allow more meaningful comparisons to
be made between adhesives.
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