Adhesively Bonded Versus Non-Bonded Amalgam Restorations For Dental Caries (Review)

Adhesively bonded versus non-bonded amalgam restorations
for dental caries (Review)

Fedorowicz Z, Nasser M, Wilson N
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2009, Issue 4
http://www.thecochranelibrary.com
Adhesively bonded versus non-bonded amalgam restorations for dental caries (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
PLAIN LANGUAGE SUMMARY .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
RESULTS . . . . . . . . . .
DISCUSSION . . . . . . . .
AUTHORS CONCLUSIONS . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
CHARACTERISTICS OF STUDIES
DATA AND ANALYSES . . . . .
ADDITIONAL TABLES . . . . .
APPENDICES . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
INDEX TERMS
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[Intervention Review]
Adhesively bonded versus non-bonded amalgam restorations

for dental caries
Zbys Fedorowicz1 , Mona Nasser2 , Nairn Wilson3
1 UKCC
(Bahrain Branch), Ministry of Health, Bahrain, Awali, Bahrain. 2 Department of Health Information, Institute for Quality
and Efficiency in Health care, Cologne, Germany. 3 Kings College London Dental Institute at Guys, Kings College and St Thomas
Hospitals, London, UK
Contact address: Zbys Fedorowicz, UKCC (Bahrain Branch), Ministry of Health, Bahrain, Box 25438, Awali, Bahrain.
zbysfedo@batelco.com.bh.
Editorial group: Cochrane Oral Health Group.
Publication status and date: New, published in Issue 4, 2009.
Review content assessed as up-to-date: 23 July 2009.
Citation: Fedorowicz Z, Nasser M, Wilson N. Adhesively bonded versus non-bonded amalgam restorations for dental caries. Cochrane
Database of Systematic Reviews 2009, Issue 4. Art. No.: CD007517. DOI: 10.1002/14651858.CD007517.pub2.
ABSTRACT
Background
Dental caries (tooth decay) is one of the commonest diseases which afflicts mankind, and has been estimated to affect up to 80% of
people in high-income countries. Caries adversely affects and progressively destroys the tissues of the tooth, including the dental pulp
(nerve), leaving teeth unsightly, weakened and with impaired function. The treatment of lesions of dental caries, which are progressing
through dentine and have caused the formation of a cavity, involves the provision of dental restorations (fillings).
Objectives
To assess the effects of adhesive bonding on the in-service performance and longevity of restorations of dental amalgam.
Search methods
Databases searched July 2009: the Cochrane Oral Health Groups Trials Register; CENTRAL (The Cochrane Library 2009, Issue 3);
MEDLINE (1950 to July 2009); and EMBASE (1980 to July 2009).
Selection criteria
Randomised controlled trials comparing adhesively bonded versus traditional non-bonded amalgam restorations in conventional
preparations utilising deliberate retention, in adults with permanent molar and premolar teeth suitable for Class I and II amalgam
restorations only.
Data collection and analysis
Two review authors independently screened papers, extracted trial details and assessed the risk of bias in the included study.
Main results
One trial with 31 patients who received 113 restorations was included. At 2 years only 3 out of 53 restorations in the non-bonded group
were lost, which was attributed to a lack of retention, and 55 of 60 bonded restorations survived with five unaccounted for at followup. Post-insertion sensitivity was not significantly different (P > 0.05) at baseline or 2-year follow-up. No fractures of tooth tissue were
reported and there was no significant difference between the groups or matched pairs of restorations in their marginal adaptation (P >
0.05).
Authors conclusions
There is no evidence to either claim or refute a difference in survival between bonded and non-bonded amalgam restorations. This
review only found one methodologically sound but somewhat under-reported trial. This trial did not find any significant difference in
the in-service performance of moderately sized adhesively bonded amalgam restorations, in terms of their survival rate and marginal
integrity, in comparison to non-bonded amalgam restorations over a 2-year period. In view of the lack of evidence on the additional
benefit of adhesively bonding amalgam in comparison with non-bonded amalgam, it is important that clinicians are mindful of the
additional costs that may be incurred.
PLAIN LANGUAGE SUMMARY

Adhesively or non-adhesively bonded amalgam restorations for dental caries
Tooth decay is a common problem affecting both children and adults. Cavities form in the teeth by the action of acid producing
bacteria present in dental plaque.
A number of techniques and a variety of materials can be used to restore teeth and one of the most commonly used and comparatively
cheap filling material is dental amalgam (a mixture of mercury and metal alloy particles). The review authors sought to evaluate the
added benefit of using an adhesive to bond amalgam to tooth structure to see if bonded fillings would last longer.
Only one study, which provided limited data, showed that for medium sized fillings there was no difference in sensitivity between the
bonded and non-bonded fillings after their placement and that bonding of amalgam to tooth did not have any effect on the survival
of the filling over a 2-year period and thus the time taken for the additional step in addition to the cost of bonding material cannot be
justified.
BACKGROUND
Dental caries (tooth decay) is one of the commonest diseases which
afflicts mankind, and has been estimated to affect up to 80% of
people in high-income countries (Chadwick 2001). Caries is a
term used to denote both lesions of caries and the carious process,
the demineralisation of enamel, dentine and cementum caused by
organic acids produced by acidogenic bacteria in dental plaque.
Across the world the incidence and severity of caries is strongly
associated with social deprivation, with a focus in children and, increasingly, older people who have retained a number of their natural teeth (WHO 2005). Despite caries being preventable through,
in particular, effective oral hygiene, dietary control and the use of
anticariogenic agents, notably fluoride in toothpastes and when
administered systemically, it is anticipated to remain a common
disease for the foreseeable future, with the prevalence being greatest in many of the developing countries (Yee 2002) .
Consequences of caries
Caries adversely affects and progressively destroys the tissues of the
tooth, including the dental pulp (nerve), leaving teeth unsightly,
weakened and with impaired function, subsequent to the disease

process causing parts of the teeth to cavitate and fracture under
loading. Carious teeth can become painful when advancing lesions
of caries cause pulpal inflammation. If untreated pulpal inflammation becomes irreversible and the pulp dies, with the possibility
of infection passing out of the tooth to cause a dental abscess.
Caries is an opportunistic, infectious disease responsible for a great
deal of human suffering. Where dental healthcare systems exist,
caries is responsible for a substantial financial burden which increases with recurrence of the disease process (Burke 2001; Yee
2002).
Treatment
The treatment of lesions of dental caries, which are progressing
through dentine and have caused the formation of a cavity, involves
the provision of dental restorations (fillings). Restorations can be
of many different forms and various materials, with variations in
technique sensitivity and durability.
Dental amalgam
Despite many important developments in dental materials and
minimally interventive techniques, in many parts of the world
most restorations tend to continue to be of a traditional form and
of the material most widely used in dentistry over at least the last
100 years i.e. dental amalgam (Berry 1998). This material, a combination of mercury and alloy particles of different compositions
and form is cost effective in the management of dental caries, but
lacking many of the features of an ideal dental filling material
(Downer 1999; Mackert 2004).
A major limitation of dental amalgam, other than its poor appearance, is its inability to bond to remaining tooth tissues, and thereby
form a seal between restoration and tooth. This limitation is to a
variable extent countered by dental amalgam corrosion products
building up in the restoration/tooth interface, and thereby helping to limit the negative effects of the interfacial percolation of
oral fluids, including cariogenic bacteria and their food substrate
of fermentable carbohydrates (Ben-Amar 1995).
Bonding
With the development of systems to bond tooth-coloured dental
filling materials to calcified tooth tissues (enamel and dentine),
there were investigations to determine if bonding systems could
be applied to dental amalgams, and thereby address certain limitations in the use of such metallic materials (Turner 1995). These
investigations, which included a small number of short duration
clinical studies were considered, at the turn of the century, to indicate that there was evidence accruing clinically that the bonding
of dental amalgams could be used, despite its technique sensitivity
and technical difficulties, to extend the range of usage of dental
amalgam to non-retentive conservative preparations and, toward
the other extreme, as an adjunct to other forms of retention in
large compound (complex) restorations (Setcos 2000) thereby offering opportunity to conserve sound tooth structure.
Given the above and the recognition that dental amalgams will,
for the foreseeable future, remain the material of choice for certain
restorations in posterior teeth, including the replacement therapy
for existing amalgam fillings (SCENIHR 2007), it is considered
important to undertake a systematic review of recent clinical findings on adhesively bonded versus non-bonded amalgam restorations in the management of dental caries. This review builds on earlier non-Cochrane reviews which assessed the longevity of routine
dental restorations (Chadwick 2001; Downer 1999), and whilst
there are differing views over the point at which restorations may
require replacement there is a consensus that the survival time for
amalgam fillings is within a range of 10 to 20 years.
OBJECTIVES
To assess the effects of adhesive bonding on the in-service performance and longevity of dental amalgam restorations.
METHODS
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials (RCTs) to include paired
tooth and split-mouth study designs, with a minimum length of
follow-up of 2 years. The unit of randomisation considered was
either at the level of the tooth or the individual patient.
Only studies that assessed the in-service performance and longevity
of restorations using clearly defined criteria e.g. United States Public Health Service (USPHS) or any recognised modifications to
these criteria were included in the review (Hickel 2007).
Types of participants
Adults and adolescents with permanent posterior molar and premolar teeth suitable for Class I and II, but excluding Class V, amalgam restorations.
Types of interventions
Adhesively bonded versus traditional non-bonded amalgam
restorations in conventional preparations utilising deliberate retention. All types of bonding agents were considered.
Types of outcome measures

The main outcome of interest was the longevity/survival of the
restorations as assessed by clinical examination and defined by the
USPHS criteria, Ryge criteria or modifications of these scales (Ryge
1981). Longevity represents the survival rate of the restorations
at specified time points or at completion of the study. Failure
is defined as the total mechanical failure of the restoration i.e.
mobility, fracture, missing in part or in total or the death of the
pulp and/or catastrophic failure leading to the extraction of the
tooth.
Although we intended categorising outcome data at defined time
points, in order that we capture data on early failures there was no
minimum follow-up.
Primary outcomes
The nature of the primary outcome data (survival/failure) sought

in this review was principally dichotomous.
1. Survival of the restoration: longevity/survival to defined
time points yearly up to a maximum of 10 years and if available:
time-to-first-event and failure-free survival presented as the
proportion of restorations placed that survived after a designated
period of time of 1, 2, 5 and 10 years.
Secondary outcomes
1. Post-insertion sensitivity or pain assessed by a validated

pain scale.
2. Secondary caries, as diagnosed clinically.
3. Marginal deterioration of the restoration and fracture of the
remaining tooth tissue.
4. Economic data: direct costs of materials and any reported
associated indirect costs.
5. Adverse effects: any event for which the causal relationship
between the event and the amalgam restoration is at least a
reasonable possibility.
Search methods for identification of studies
for details of additional published and unpublished trials. We did

not handsearch any journals.
Language
There was no language restriction on included studies and we

identified one potentially relevant study in the Chinese language
which was translated into English.
Data collection and analysis
Selection of studies
Two review authors (Zbys Fedorowicz (ZF) and Nairn Wilson
(NW)) independently assessed the abstracts of studies resulting
from the searches. We obtained full copies of all relevant and
potentially relevant studies, those appearing to meet the inclusion
criteria, and for which there were insufficient data in the title and
abstract to make a clear decision. The full text papers were assessed
independently by the two review authors and any disagreement on
the eligibility of included studies was resolved through discussion
and consensus or if necessary through a third party (Mona Nasser
(MN)). We excluded all irrelevant records and noted details of the
studies and the reasons for their exclusion in the Characteristics
of excluded studies table in RevMan 5 (RevMan 2008).
Electronic searches
For the identification of studies included or considered for this
review, detailed search strategies were developed for each database
to be searched. These were based on the search strategy developed
for MEDLINE (Appendix 1) but revised appropriately for each
database.
For the MEDLINE search, we ran the subject search with the
Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomised trials in MEDLINE: sensitivity maximising version (2008 revision) as referenced in Chapter 6.4.11.1 and detailed
in box 6.4.c of the Cochrane Handbook for Systematic Reviews of
Interventions 5.0.1 (updated September 2008) (Higgins 2008).
We searched the following databases on 22nd July 2009:
the Cochrane Oral Health Groups Trials Register;
the Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library 2009, Issue 3);
MEDLINE (1950 to 2009); and
EMBASE (1980 to 2009).
For the detailed search strategies applied to each of the databases
see Appendix 2; Appendix 3 and Appendix 4.
Searching other resources

We examined the reference lists of relevant articles and contacted
the investigators of the included study by electronic mail to ask
Data extraction and management

We entered study details into the Characteristics of included
studies table in RevMan 5 and collected outcome data using a predetermined form designed for this purpose.
Data were extracted independently and in duplicate by two review
authors (ZF and MN) and only included if there was a consensus.
The following details were extracted.
1. Trial methods: (a) method of allocation; (b) masking of
participants, trialists and outcome assessors; (c) exclusion of
participants after randomisation and proportion and reasons for
losses at follow -up.
2. Participants: (a) country of origin and location: private
clinic or academic institute; (b) sample size; (c) age; (d) sex; (e)
inclusion and exclusion criteria; (f ) location and type of cavity
(Class I or II); (g) cavity size.
3. Intervention: (a) type, amalgam alloy and bonding material
and method of cure; (b) length of time in follow-up; (c) failure
and reasons for failure if reported.
4. Control: (a) type of amalgam alloy; (b) length of time in
follow-up; (c) failure and reasons for failure if reported.
5. Outcomes: (a) primary and secondary outcomes mentioned
in the Types of outcome measures section of this review.
If stated, the sources of funding of any of the included studies were
recorded.
The review authors used this information to help them assess heterogeneity and the external validity of any included trials.
Assessment of risk of bias in included studies

Each review author graded the selected trial using a simple contingency form and followed the domain-based evaluation described
in Chapter 8 of the Cochrane Handbook for Systematic Reviews of
Interventions 5.0.1 (Higgins 2008). The evaluations were compared and any inconsistencies between the review authors were
discussed and resolved.
The following domains were assessed as Yes (i.e. low risk of bias),
Unclear (i.e. uncertain risk of bias) or No (i.e. high risk of bias):
1. sequence generation;
2. allocation concealment;
3. blinding (of participants, personnel and outcome assessors);
4. incomplete outcome data;
5. selective outcome reporting;
6. free of other bias.
Risk of bias in any included studies was categorised according to
the following:
Low risk of bias (plausible bias unlikely to seriously alter the
results) if all criteria were met;
Unclear risk of bias (plausible bias that raises some doubt
about the results) if one or more criteria were assessed as unclear;
or
High risk of bias (plausible bias that seriously weakens
confidence in the results) if one or more criteria were not met.
These assessments are reported in the Risk of bias in included
studies table.
As one of the review authors (NW) was an investigator in the only
included study he did not participate in either the assessment of
risk of bias or in data extraction.
section 10.4.3.1 of the Cochrane Handbook for Systematic Reviews

of Interventions 5.0.1 (Higgins 2008), and if asymmetry is identified, we will try to assess other possible causes and these will be
explored in the discussion if appropriate.
Data synthesis
As only one study was included in this review, data synthesis was
not feasible but if further studies are identified for inclusion in this
review, the following methods will be used.
Two review authors (ZF and MN) will analyse the data and report them as specified in Chapter 9 of the Cochrane Handbook for
Systematic Reviews of Interventions 5.0.1 (Higgins 2008). Analysis
will be conducted at the same level as the allocation.
Choice of summary statistic and estimate of overall

effect
We will transform longevity/survival data to dichotomous outcomes (failure/not). Risk ratios and their 95% confidence intervals
will be calculated for all dichotomous data. The mean difference
and 95% confidence intervals will be calculated for continuous
data.
As it is likely that the timing of outcome assessment will vary
between studies we will consider grouping the data according to
the following time points: 1, 2, 5 and 10 years.
Pooling of data to provide estimates of the efficacy of the interventions would only be undertaken if the included studies have
similar interventions received by similar participants. In the event
of substantial clinical heterogeneity between the studies we intend
using the random-effects model with studies grouped by action.
Subgroup analyses
Assessment of heterogeneity
A lack of included studies precluded any assessment of heterogeneity but if further trials are identified the following methods
will be used.
We will assess clinical heterogeneity by examining the characteristics of the studies, the similarity between the types of participants,
the interventions and the outcomes as specified in the criteria for
included studies. Statistical heterogeneity will be assessed using a
Chi2 test and the I2 statistic where I2 values over 50% indicate
moderate to high heterogeneity. We will consider heterogeneity to
be significant when the P value is less than 0.10 (Higgins 2003).
Subgroup analyses will be conducted for any of the following:

different bonding agents, the type of cavity (Class I or II) and
its location (premolar or molar tooth), only if there are sufficient
numbers of included trials with appropriate data.
Sensitivity analyses
If sufficient studies are included we plan to conduct sensitivity
analyses to assess the robustness of our review results by repeating
the analysis with the following adjustments: exclusion of studies
with unclear or inadequate allocation concealment, unclear or inadequate blinding of outcomes assessment and completeness of
follow-up.
Assessment of reporting biases

If further trials are identified for inclusion in this review, publication bias will be assessed according to the recommendations on
testing for funnel plot asymmetry (Egger 1997) as described in
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
pairs of teeth (split-mouth) in addition to single restorations. Participants received appropriate oral hygiene instruction and support prior to treatment and were seen more regularly for dental
examinations and tooth cleaning during the course of the study.
Results of the search
Characteristics of the interventions
De-duplication of the search results produced 437 references to

potentially eligible studies. After examination of the titles and
abstracts of these references, all but seven (Browning 2000; Mach
2002; McEvoy 1992; McEvoy 1993; Mahler 1996; Setcos 1999;
Xia 2002) were eliminated and excluded from further review. Full
text copies of these remaining studies were obtained and then
subjected to further evaluation which included an examination
of their bibliographical references which provided no additional
citations to potentially eligible trials.
We arranged to translate (Xia 2002) from the Chinese to the English language. From the translated version of this study we noted
that neither the inclusion criteria nor the interventions used were
explicitly described and that the outcome data were incompletely
reported. Poor methodological rigour and the possibility of high
risk of bias coupled with our lack of success in contacting the investigators resulted in its exclusion.
The review authors discussed the eligibility of the potentially eligible studies, resolved any uncertainties by consensus and finally excluded all the studies, see Characteristics of excluded studies, with
the exception of Setcos 1999 which met our inclusion criteria and
was included in this review.
The majority of these were replacements for defective restorations

in which some of the preparations had pre-existing retention and
undercuts. Cavity preparation consisted of conservative excavation of caries with minimal removal of sound tooth tissue and the
investigators indicated that no attempt was made to provide additional deliberate retention through either grooves or undercuts. In
a subsequent communication with one of the trialists it was confirmed that, to reduce interoperator variability, all the restorations
were placed by the same dentist.
In the adhesive group (60 teeth), ED primer was applied to the
preparation with a sponge pellet for 60 seconds and dried with an
air syringe. Panavia 21TC was applied with a brush and left for 60
seconds, the cavity was filled incrementally with amalgam and then
carved and burnished. The margins were covered with Oxyguard
II gel to allow setting of the adhesive cement. The materials were
handled according to manufacturers instructions, and standard
clinical procedures were used for finishing and polishing of the set
amalgam.
The restorative procedures used in the non-adhesive group (53
teeth) were identical but excluded the use of adhesive, varnish or
any similar material.
Included studies
Characteristics of the trial setting and investigators
Setcos 1999 was a single centre prospective randomised controlled

trial which was conducted in the UK but the report provided no
further details about the setting. The providers and assessors of
treatment were university research staff.
Although the investigators indicated that the study was supported
by Kuraray Co Ltd, Osaka, Japan they did not specify the level of
support nor did they declare any potential conflicts of interest.
Characteristics of the participants
Very limited demographic details were presented in the report

other than that the participants were drawn from a healthy population with no contraindications to routine dental treatment,
and required Class II (two or three surface) restorations in vital
posterior teeth. The investigators stated that they sought to utilise
contralateral pairs of teeth such that in-mouth comparisons could
be made and thus the design of the study incorporated 35 matched
Characteristics of outcome measures
Outcome assessments were made by two dentists, who were experienced in rating restorations, within the first month post-intervention (baseline) and at a 2-year follow-up. The assessments were
made independently by both evaluators at each recall visit and any
discrepancies in the ratings were discussed and agreed by consensus. The number of failed restorations was recorded, where failure
referred to a restoration which had been dislodged and lost. Participants were also questioned at these time points about thermally
sensitivity, which was rated according to the modified USPHS criteria: A (Alpha): tooth not temperature sensitive, or momentary
slight sensitivity; B (Bravo): tooth moderately temperature sensitive, but does not linger; C (Charlie): tooth severely temperature
sensitive.
Further details of this trial can be found in the Characteristics of
included studies table.
Excluded studies
Six studies were excluded; two (McEvoy 1992; McEvoy 1993) were
surveys; Mahler 1996 was a non-randomised study and Xia 2002
lacked methodological rigour. The decision to exclude Browning
2000 was based on our categorisation of this study at high risk
of (selection) bias for the outcomes of interest in addition to the

incompleteness of its data as a result of the large number of withdrawals. We eliminated the Mach 2002 study from this review
because it included teeth with lesions other than Class II, as well
as the lack of clarity and consistency in the reporting of the interventions participants received as well as in the presentation of the
outcome data. See Characteristics of excluded studies table.
Risk of bias in included studies

We were successful in contacting another one of the study investigators by email who was able to clarify some missing trial details
which enabled a change in both the assessment of concealed randomisation and blinded assessment of outcomes from unclear to
yes to be made for this study.
As all of the criteria used in the assessment of risk of bias were met,
this trial was assessed as low risk of bias (plausible bias unlikely to
seriously alter the results). Further details of these assessments are
available in the Risk of bias in included studies table.
Effects of interventions
The single included trial provided a limited amount of data relevant to some of the primary and secondary outcomes of this review and therefore we have not entered these into the RevMan
analysis but present these data in the Additional tables section of
this review together with a descriptive summary. In addition, we
note that although the data analysis in this trial failed to take into
account the clustering of matched pairs of teeth it was considered
that this would have a limited impact on the overall results.
(1) Post-insertion sensitivity or pain assessed by a validated

pain scale
Only the modified USPHS criteria were used to rate post-insertion temperature sensitivity at both baseline and at the 24-month
assessment. Although the investigators indicated that there was no
significant difference in sensitivity between the two groups (P >
0.05), this conclusion appeared to be based on the assessments
made solely at these two time points. However, because such ordinal ratings of severity are unlikely to be sufficiently sensitive in
providing a discriminative assessment of post-operative sensitivity
when compared with a validated VAS we have not reported these
data.
(2) Secondary caries, as diagnosed clinically
The report provided no data for this outcome.
(3) Marginal deterioration of the restoration and fracture of

the remaining tooth tissue
No fractures of remaining tooth tissue were reported in either of

the intervention groups. The marginal deterioration of restorations was assessed at the occlusal and proximal surfaces, and the
investigators reported that there was no significant difference between the groups or the matched pairs of restorations in their marginal adaptation (P > 0.05), and that these provided comparable
Alpha rating scores at both baseline and 24 months. See Additional
Table 2.
Although not discussed by the investigators, the apparent improvement in Alpha scores (88% to 91%) in the proximal assessment
in the bonded group at 24 months may reflect the subsequent
replacement of the three failed non-bonded restorations with adhesively bonded restorations and is consistent with their survival
at the 24-month recall.
Primary outcomes
(4) Economic data: direct costs of materials and any
reported associated indirect costs
(1) Survival of the restoration: longevity/survival to defined
time points yearly up to a maximum of 10 years
Only three restorations (non-bonded) were reported as lost at 4,

7 and 24 months, and in all three the loss of proximal boxes was
attributed to a lack of retention (Additional Table 1). It was unclear how many, if any, of the five bonded restorations which were
unavailable at the 24-month recall could be classified as failures.
Although this study had a large percentage follow-up at 24 months,
which permitted an assessment of 105/113 (93%) of the restorations placed, the number of failures proved to be very small, and
therefore we did not conduct a survival analysis.
Secondary outcomes
No data were reported.

(5) Adverse effects
The investigators did not report any adverse effects.

For further details of this trial see the Characteristics of included
studies table.
DISCUSSION
The paucity of high quality trials evaluating the effects of adhesive
bonding on the in-service performance and longevity of restorations of dental amalgam proved to be somewhat disappointing
more especially because of the availability and usage, by clinicians,

of a wide range of bonding agents that have been developed over
a number of years.
The single randomised controlled trial, albeit only of short duration, which was included in this review would appear to confirm some of the findings of several other studies in that moderately sized adhesively bonded amalgam restorations have a similar
survival profile and clinical performance to non-bonded restorations. However, whilst attempts were made in this study to ensure
that the preparations for bonded restorations had limited retentive form compared to conventional preparations utilising deliberate retention, such that assessment could be made of the added
value of bonding, there can be no certainty that this is reflected
by the similarity of survival data in both treatment groups chiefly
because of the difficulties of eliminating all potential sources of
retention. Although these similarities may suggest that there is reliable evidence for the effectiveness of bonding agents they also
indicate that adhesive bonding of dental amalgam restorations has
neither beneficial nor detrimental effects on clinical performance,
as assessed by modified USPHS over periods of up to 2 years after
placement, and therefore calls into question the additional cost of
materials and time expended on bonding.
Whilst recognising some of the complexities of assessing post-operative sensitivity for these interventions, the apparent lack of temperature sensitivity in the two groups may be potentially misleading. The absence of temperature sensitivity at the 24-month recall
could in any event be indicative of post-operative loss of vitality
and in particular if there was immediate post-insertion hypersensitivity. This lack of detailed information about any immediate
post-insertion sensitivity or pain and in particular its duration and
intensity due to any stimulus as assessed with a VAS was a further,
small but not insignificant, limitation of this study.
Even though the clinical trial that was included in this systematic
review satisfied our inclusion criteria, the generalisability of its
results are likely to be compromised by several factors: the selection
of patients from a university dental hospital environment, which
could be considered unrepresentative of the population at large, as
well as the comparative freedom from some of the constraints, e.g.
time and cost of materials, which might apply in general dental
practice.
AUTHORS CONCLUSIONS
Implications for practice
There is no evidence to either claim or refute a difference in survival
between bonded and non-bonded amalgam restorations. This re-
view only found one methodologically sound but somewhat under-reported trial. This trial did not find any significant difference in the in-service performance of moderately sized adhesively
bonded amalgam restorations, in terms of their survival rate and
marginal integrity, in comparison to non bonded amalgam restorations over a two year period. In view of the lack of evidence on
the additional benefit of adhesively bonding amalgam in comparison with non bonded amalgam, it is important that clinicians are
mindful of the additional costs that may be incurred.
Implications for research

Following the realisation that dental amalgam may be adhesively
bonded to enamel and dentine, there was a need to investigate
the clinical performance of bonded amalgams, in particular, in
cavities in which no effort had been made to introduce retention
features. With subsequent developments in respect of, in particular, minimal interventive dentistry and enhanced durability and,
in turn, longevity of tooth-coloured alternatives to dental amalgam, the need for further investigations of the efficacy of adhesively bonded restorations of dental amalgam has diminished. Indeed, further clinical investigations on adhesively bonded dental amalgams would be difficult to justify. A further deterrent to
considerations to plan further clinical investigations of adhesively
bonded restorations of dental amalgam is the cost consideration
of the bonding process. Notwithstanding the not inconsiderable
cost of the adhesive materials, the adhesive bonding of restorations of dental amalgams adds greatly to the placement time of
such restorations. Extended treatment times, let alone additional
cost, which add little, if anything to clinical outcomes cannot be
supported.
Given the available evidence and the diminishing use of dental amalgam internationally, there is conceivably limited justification for further clinical investigations on the adhesive bonding of
restorations of dental amalgam.
ACKNOWLEDGEMENTS
The review authors would like to thank the Cochrane Oral Health
Group and the peer reviewers and referees for their help in conducting this systematic review. We would also like to thank Professor Jin Xuejuan of the Shanghai Institute of Cardiovascular Diseases who very kindly obtained a full text copy of one of the trials,
to Dr Edwin Chan Shih-Yen the Director of the Singapore Branch
of the Australasian Cochrane Centre for carrying out the translation of this paper and Dr Bruce Manzer of The College of Health
Sciences at the Ministry of Health Bahrain for help with editing
earlier drafts of this review.
REFERENCES
References to studies included in this review

Setcos 1999 {published data only}
Setcos JC, Staninec M, Wilson NH. A two-year
randomized, controlled clinical evaluation of bonded
amalgam restorations. Journal of Adhesive Dentistry 1999;1
(4):32331.
References to studies excluded from this review

Browning 2000 {published data only}
Browning WD, Johnson WW, Gregory PN. Clinical
performance of bonded amalgam restorations at 42 months.
Journal of the American Dental Association 2000;131(5):
60711.
Mach 2002 {published data only}
Mach Z, Regent J, Staninec M, Mrklas L, Setcos JC.
The integrity of bonded amalgam restorations: a clinical
evaluation after five years. Journal of the American Dental
Association 2002;133(4):4607.
Mahler 1996 {published data only}
Mahler DB, Engle JH, Simms LE, Terkla LG. One-year
clinical evaluation of bonded amalgam restorations. Journal
of the American Dental Association 1996;127(3):3459.
McEvoy 1992 {published data only}
McEvoy SA, Richards ND, McConnell TA, Mitchell RJ.
Lesion size and retention of dentin-bonded restorations.
Journal of Dental Research. 1992; Vol. 71:139 (Abs No
266).
McEvoy 1993 {published data only}
McEvoy SA, Richards ND, McConnell TA, Mitchell RJ.
Age, lesion size and retention of dentin-bonded restorations.
Journal of Dental Research. 1993; Vol. 72:380 (Abs No
2216).
Xia 2002 {published data only}
Xia SL, Liu JB, Li TL. Clinical study of amalgam restoration
with resin multi-purpose adhesive agent. Bulletin of Hunan
Medical University 2002;27(3):238.
Additional references
Ben-Amar 1995
Ben-Amar A, Cardash HS, Judes H. The sealing of the
tooth/amalgam interface by corrosion products. Journal of
Oral Rehabilitation 1995;22(2):1014.
Berry 1998
Berry TG, Summitt JB, Chung AK, Osborne JW. Amalgam
at the new millennium. Journal of the American Dental
Association 1998;129(11):154756.
Burke 2001
Burke FJ, Wilson NH, Cheung SW, Mjor IA. Influence of
patient factors on age of restorations at failure and reasons
for their placement and replacement. Journal of Dentistry
2001;29(5):31724.
Chadwick 2001
Chadwick BL, Dummer PMH, Dunstan F, Gilmour A,
Jones R, et al.A systematic review of the longevity of dental
restorations. NHS Centre for Reviews and Dissemination,
University of York 2001; Vol. Report number 19.
Downer 1999
Downer MC, Azli NA, Bedi R, Moles DR, Setchell DJ.
How long do routine dental restorations last? A systematic
review. British Dental Journal 1999;187(8):4329.
Egger 1997
Egger M, Davey-Smith G, Schneider M, Minder C. Bias
in meta-analysis detected by a simple, graphical test. BMJ
1997;315:62934.
Hickel 2007
Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters
M, et al.Recommendations for conducting controlled
clinical studies of dental restorative materials. Clinical Oral
Investigations 2007;11(1):533.
Higgins 2003
Higgins JP, Thompson SG, Deeks JJ, Altman DG.
Measuring inconsistency in meta-analyses. BMJ 2003;327
(7414):55760.
Higgins 2008
Higgins JPT, Green S (editors). Cochrane Handbook for
Systematic Reviews of Interventions Version 5.0.1 [updated
September 2008] The Cochrane Collaboration, 2008.
Available from www.cochrane-handbook.org.
Mackert 2004
Mackert JR, Wahl MJ. Are there acceptable alternatives to
amalgam?. Journal of the California Dental Association 2004;
32(7):60110.
RevMan 2008
The Nordic Cochrane Centre, The Cochrane Collaboration.
Review Manager (RevMan). 5.0. Copenhagen: The Nordic
Cochrane Centre, The Cochrane Collaboration, 2008.
Ryge 1981
Ryge G. Clinical criteria. International Dental Journal 1981;
30(4):34758.
SCENIHR 2007
Scientific Committee on Emerging and Newly Identified
Health Risks (SCENIHR). The safety of dental amalgam
and alternative dental restoration materials for patients and
users. Available at: http://ec.europa.eu/health/ph_risk/
committees/04_scenihr/scenihr_cons_07_en.htm [Accessed
28 March 2008].
Setcos 2000
Setcos JC, Staninec M, Wilson NH. Bonding of amalgam
restorations: existing knowledge and future prospects.
Operative Dentistry 2000;25(2):1219.
Turner 1995
Turner EW, St Germain HA, Meiers JC. Microleakage
of dentin-amalgam bonding agents. American Journal of
Dentistry 1995;8(4):1916.
WHO 2005
Sheiham A. Oral health, general health and quality of life.
Bulletin of the World Health Organization 2005; Vol. 83,
issue 9:644.
Yee 2002
Yee R, Sheiham A. The burden of restorative dental
treatment for children in Third World countries.
International Dental Journal 2002;52(1):19.
Indicates the major publication for the study
10
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Setcos 1999
Methods
2-year randomised controlled trial, no details of the setting or date of the trial were
reported
Participants
31 (21 males, 10 females, no age specified).

Inclusion criteria: no contraindication to routine dental treatment, routine radiographs
taken, attempts made to find contralateral pairs of teeth
Class II restorations [mo, do or mod] in vital posterior teeth
Interventions
N = 113 restorations. Size, location and number per participant were unreported but 35
matched pairs were compared and analysed
No deliberate provision of undercuts or retention in any preparations
Group 1: 60 adhesively bonded amalgam restorations. Dycal (LD Caulk) liner; ED
primer (Kuraray); Panavia 21TC (Kuraray); Oxyguard II gel (Kuraray); Dispersalloy
amalgam (Dentsply)
Group 2: 53 non-bonded amalgam restorations. Dycal (LD Caulk) liner; Dispersalloy
amalgam (Dentsply)
Outcomes
Clinical assessments: baseline (< 1 month post-intervention) and at 2 years, utilising

modified USPHS criteria. Failure not clearly defined, appears to refer to total or partial
loss of the box part of the restoration
Assessment of post-intervention sensitivity at baseline and at 2 years using USPHS criteria
Notes
The study was supported by Kuraray Co Ltd, Japan, the manufacturer of the adhesive
materials used in this study
Risk of bias
Item
Authors judgement
Description
Adequate sequence generation?
Yes
Quote (from report): By random assignment.., and At this stage, the operators
were shown the random selection for the
method of filling
Comment: Unclear how and by whom the
random sequence was generated
Quote (from correspondence): This was
done by a specially prepared random allocation of adhesive/non-adhesive treatments
which was followed through sequentially
Comment: Probably done.
Allocation concealment?
Yes
Comment: Nothing reported.

Quote (from correspondence): The random allocation was prepared by the statis-
11
Setcos 1999
(Continued)
tical support unit at Manchester University

Dental Hospital
Comment: Central allocation by a third
party.
Blinding?
All outcomes
Yes
Participants: No information available, but

most likely blinded to the interventions
Healthcare providers: Impossible to blind
operators to the interventions
Outcome assessors and data analysts:
Quote (from report): Clinical evaluation by two dentists, experienced in rating restorations, was performed at baseline
(within one month of placement), and at
two years following placement
Quote (after correspondence): the person
who placed the restorations not being involved in the recall assessments
Comment: Probably done.
Patient reported outcomes: Only post-operative sensitivity, and most probable if participants blinded to interventions
Incomplete outcome data addressed?

All outcomes
Yes
Losses to follow-up at 2-year assessment

were accounted for.
Adhesively bonded: 5/60 (0.08%); participants not available for assessment and unclear whether these restorations had failed.
Non-bonded: 3/53 (0.06%); losses at 4
months, 7 months and 24 months.
Missing data proportionately balanced
across intervention groups
Free of selective reporting?
Yes
Although the study protocol was not available, the report appears to include all prespecified and expected outcomes
Free of other bias?
Yes
The study was supported by the manufacturer of a relevant dental product but appears to be free of other sources of bias
12
Characteristics of excluded studies [ordered by study ID]
Study
Reason for exclusion
Browning 2000
Follow-up study assessing clinical performance. Previous study an RCT (1-week post-op sensitivity evaluation),
but only 39 out of the original 60 participants were selected to take part in this follow-up. A further 8/39 withdrew
before the end of this study. The decision to exclude this study was based on the high risk of (selection) bias for
the outcomes of interest and incomplete data due to the high number of withdrawals (attrition)
Mach 2002
Comparative study: all restorations were Class II and all preparations, with the exception of six in the bonded
group which were non-retentive, included dovetail retention
Quote (from report): After preparation the dentist decided by a coin toss whether the lesion would be restored
with or without adhesive.
Comment: Sequence generation and concealment of allocation inadequate
The interventions included six preparations for small proximal lesions that did not involve the occlusal surface i.e.
were not Class II and these were not included in the random allocation but were all included in the adhesive group
Over and above the methodological limitations to this study there were some inconsistencies and lack of clarity in
the reporting of interventions received, and in the presentation of data
Mahler 1996
Non-randomised study.
McEvoy 1992
Abstract to conference proceedings, a survey.
McEvoy 1993
Abstract to conference proceedings as McEvoy 1992.
Xia 2002
Translated from Chinese to English language. Incomplete trial details: sequence generation, inclusion criteria and
interventions unclear, outcomes defined only as efficacy, inconsistency in outcome data and analysed numbers
fewer than randomised numbers. No explanation for losses.
RCT = randomised controlled trial
13
DATA AND ANALYSES

This review has no analyses.
ADDITIONAL TABLES
Table 1. Successful or failed restorations at 24 months
Adhesively bonded
Non-bonded
Success
Failure
Success
55/60
5 restorations unavailable at 24- 50/53

month follow-up
Failure
3 (5.7%)
Fishers Exact test P = 0.115
Table 2. Marginal adaptation USPHS Alpha ratings
Occlusal
Proximal
Adhesively bonded
Non-bonded
Adhesively bonded
Non-bonded
Baseline
97
94
88
87
24 months
96
88
91
82
All data are expressed as Alpha percentages, remaining ratings were Bravo.
APPENDICES
Appendix 1. MEDLINE (OVID) search strategy
1.
DENTAL RESTORATION, PERMANENT/
2.
DENTAL RESTORATION, TEMPORARY/
3.
((tooth or teeth or dental$ or molar$ or bicuspid$ or third-molar$) and (restor$ or fill$)).ti,ab
4.
or/1-3
5.
DENTAL AMALGAM/
14
(Continued)
6.
((dental or tooth or teeth or fill$ or restor$) and amalgam$).ti,ab
7.
or/5-6
8.
(adhesiv$ or bonded or non-bonded or bonding or non-bonding).ti,ab
9.
DENTAL BONDING/
10.
or/8-9
11.
4 and 7 and 10
Cochrane search filter for MEDLINE via OVID:

Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomised trials in MEDLINE: sensitivity maximising version
(2008 revision) as referenced in Chapter 6.4.11.1 and detailed in box 6.4.c of the Cochrane Handbook for Systematic Reviews of
InterventionsVersion 5.0.1 (updated September 2008):
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. placebo.ab.
5. drug therapy.fs.
6. randomly.ab.
7. trial.ab.
8. groups.ab.
9. or/1-8
10. animals.sh. not (humans.sh. and animals.sh.)
11. 9 not 10
Appendix 2. Cochrane Oral Health Groups Trials Register search strategy

((caries or carious or decay or lesion or demineral* or remineral*) AND (amalgam* or fill* or restor*) AND (dental bonding or
adhesiv* or bonding or non-bonding or bonded or non-bonded))
Appendix 3. CENTRAL search strategy
#1
MeSH descriptor DENTAL RESTORATION, PERMANENT this term only
#2
MeSH descriptor DENTAL RESTORATION, TEMPORARY this term only
#3
((tooth in Title, Abstract or Keywords or teeth in Title, Abstract or Keywords or dental* in Title, Abstract or Keywords
or molar* in Title, Abstract or Keywords or biscupid* in Title, Abstract or Keywords or third-molar* in Title, Abstract or
Keywords) and (restor* in Title, Abstract or Keywords or fill* in Title, Abstract or Keywords))
#4
(#1 in Title, Abstract or Keywords or #2 in Title, Abstract or Keywords or #3 in Title, Abstract or Keywords)
15
(Continued)
#5
MeSH descriptor DENTAL AMALGAM this term only
#6
((dental in Title, Abstract or Keywords or tooth in Title, Abstract or Keywords or teeth in Title, Abstract or Keywords or fill*
in Title, Abstract or Keywords or restor* in Title, Abstract or Keywords) and amalgam* in Title, Abstract or Keywords)
#7
(#5 in Title, Abstract or Keywords or #6 in Title, Abstract or Keywords)
#8
(adhesiv* in Title, Abstract or Keywords or bonded in Title, Abstract or Keywords or non-bonded in Title, Abstract or Keywords
or bonding in Title, Abstract or Keywords or non-bonding in Title, Abstract or Keywords)
#9
MeSH descriptor DENTAL BONDING this term only
#10
(#8 in Title, Abstract or Keywords or #9 in Title, Abstract or Keywords)
#11
(#4 in Title, Abstract or Keywords and #7 in Title, Abstract or Keywords and #10 in Title, Abstract or Keywords)
Appendix 4. EMBASE (OVID) search strategy
1.
DENTAL RESTORATION, PERMANENT/
2.
DENTAL RESTORATION, TEMPORARY/
3.
((tooth or teeth or dental$ or molar$ or bicuspid$ or third-molar$) and (restor$ or fill$)).ti,ab
4.
or/1-3
5.
DENTAL AMALGAM/
6.
((dental or tooth or teeth or fill$ or restor$) and amalgam$).ti,ab
7.
or/5-6
8.
(adhesiv$ or bonded or non-bonded or bonding or non-bonding).ti,ab
9.
DENTAL BONDING/
10.
or/8-9
11.
4 and 7 and 10
Filter for EMBASE via OVID:

1. random$.ti,ab.
2. factorial$.ti,ab.
3. (crossover$ or cross over$ or cross-over$).ti,ab.
4. placebo$.ti,ab.
16
5. (doubl$ adj blind$).ti,ab.

6. (singl$ adj blind$).ti,ab.
7. assign$.ti,ab.
8. allocat$.ti,ab.
9. volunteer$.ti,ab.
10. CROSSOVER PROCEDURE.sh.
11. DOUBLE-BLIND PROCEDURE.sh.
12. RANDOMIZED CONTROLLED TRIAL.sh.
13. SINGLE BLIND PROCEDURE.sh.
14. or/1-13
15. ANIMAL/ or NONHUMAN/ or ANIMAL EXPERIMENT/
16. HUMAN/
17. 16 and 15
18. 15 not 17
19. 14 not 18
HISTORY
Protocol first published: Issue 1, 2009
Review first published: Issue 4, 2009
CONTRIBUTIONS OF AUTHORS
Zbys Fedorowicz (ZF), Nairn Wilson (NW), and Mona Nasser (MN) were responsible for: organising the retrieval of papers; writing
to authors of papers for additional information; screening search results; screening retrieved papers against inclusion criteria; appraising
the quality of papers; data collection for the review; extracting data from papers; obtaining and screening data on unpublished studies.
ZF and MN entered the data into RevMan and were responsible for analysis and interpretation of the data.
All review authors contributed to writing the review.
All review authors were responsible for designing and co-ordinating the review and for data management for the review.
NW and ZF conceived the idea for the review and are the guarantors for the review.
DECLARATIONS OF INTEREST
There are no financial conflicts of interest and the review authors declare that, other than Nairn Wilson who is an investigator in
potentially eligible studies, they do not have any associations with any parties who may have vested interests in the results of this review.
INDEX TERMS
17
Medical Subject Headings (MeSH)

Dental
Restoration Failure; Dental Amalgam [ therapeutic use]; Dental Bonding [ methods]; Dental Caries [ therapy]; Dental
Restoration, Permanent [ methods]
MeSH check words

Adult; Humans
18

Adhesively Bonded Versus Non-Bonded Amalgam Restorations For Dental Caries (Review)

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PLAIN LANGUAGE SUMMARY

weakened and with impaired function, subsequent to the disease

Criteria for considering studies for this review

Types of outcome measures

The nature of the primary outcome data (survival/failure) sought

1. Post-insertion sensitivity or pain assessed by a validated

Search methods for identification of studies

for details of additional published and unpublished trials. We did

There was no language restriction on included studies and we

Data collection and analysis

Searching other resources

Data extraction and management

Assessment of risk of bias in included studies

section 10.4.3.1 of the Cochrane Handbook for Systematic Reviews

Choice of summary statistic and estimate of overall

Subgroup analyses will be conducted for any of the following:

Assessment of reporting biases

Results of the search

Characteristics of the interventions

De-duplication of the search results produced 437 references to

The majority of these were replacements for defective restorations

Characteristics of the trial setting and investigators

Setcos 1999 was a single centre prospective randomised controlled

Characteristics of the participants

Very limited demographic details were presented in the report

Characteristics of outcome measures

of (selection) bias for the outcomes of interest in addition to the

Risk of bias in included studies

(1) Post-insertion sensitivity or pain assessed by a validated

The report provided no data for this outcome.

(3) Marginal deterioration of the restoration and fracture of

No fractures of remaining tooth tissue were reported in either of

Only three restorations (non-bonded) were reported as lost at 4,

No data were reported.

The investigators did not report any adverse effects.

more especially because of the availability and usage, by clinicians,

Implications for research

References to studies included in this review

References to studies excluded from this review

Indicates the major publication for the study

Characteristics of included studies [ordered by study ID]

31 (21 males, 10 females, no age specified).

Clinical assessments: baseline (< 1 month post-intervention) and at 2 years, utilising

Adequate sequence generation?

Comment: Nothing reported.

tical support unit at Manchester University

Participants: No information available, but

Incomplete outcome data addressed?

Losses to follow-up at 2-year assessment

Free of selective reporting?

Free of other bias?

Characteristics of excluded studies [ordered by study ID]

Reason for exclusion

Abstract to conference proceedings, a survey.

Abstract to conference proceedings as McEvoy 1992.

RCT = randomised controlled trial

DATA AND ANALYSES

5 restorations unavailable at 24- 50/53

Fishers Exact test P = 0.115

Table 2. Marginal adaptation USPHS Alpha ratings