Wang Et Al-2016-Cochrane Database of Systematic Reviews

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Cochrane Database of Systematic Reviews
Rubber dam isolation for restorative treatment in dental patients

(Review)
Wang Y, Li C, Yuan H, Wong MCM, Zou J, Shi Z, Zhou X
Wang Y, Li C, Yuan H, Wong MCM, Zou J, Shi Z, Zhou X.

Rubber dam isolation for restorative treatment in dental patients.
Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD009858.
DOI: 10.1002/14651858.CD009858.pub2.
www.cochranelibrary.com
Rubber dam isolation for restorative treatment in dental patients (Review)

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 3
BACKGROUND.............................................................................................................................................................................................. 4
OBJECTIVES.................................................................................................................................................................................................. 4
METHODS..................................................................................................................................................................................................... 4
RESULTS........................................................................................................................................................................................................ 7
Figure 1.................................................................................................................................................................................................. 8
Figure 2.................................................................................................................................................................................................. 9
Figure 3.................................................................................................................................................................................................. 10
DISCUSSION.................................................................................................................................................................................................. 11
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 12
ACKNOWLEDGEMENTS................................................................................................................................................................................ 13
REFERENCES................................................................................................................................................................................................ 14
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 16
DATA AND ANALYSES.................................................................................................................................................................................... 24
Analysis 1.1. Comparison 1 Rubber dam versus cotton rolls, Outcome 1 Survival rate (6 months)................................................. 25
Analysis 1.2. Comparison 1 Rubber dam versus cotton rolls, Outcome 2 Survival rate (24 months)............................................... 25
ADDITIONAL TABLES.................................................................................................................................................................................... 25
APPENDICES................................................................................................................................................................................................. 26
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 29
DECLARATIONS OF INTEREST..................................................................................................................................................................... 29
SOURCES OF SUPPORT............................................................................................................................................................................... 29
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 29
Rubber dam isolation for restorative treatment in dental patients (Review) i

Informed decisions.
[Intervention Review]
Rubber dam isolation for restorative treatment in dental patients
Yan Wang1, Chunjie Li2, He Yuan3, May CM Wong4, Jing Zou1, Zongdao Shi5, Xuedong Zhou3
1Department of Pediatric Dentistry, West China Hospital of Stomatology, Sichuan University, State Key Laboratory of Oral Diseases,
Chengdu, China. 2Department of Head and Neck Oncology, West China Hospital of Stomatology, Sichuan University, State Key
Laboratory of Oral Diseases, Chengdu, China. 3Department of Operative Dentistry and Endodontics, West China Hospital of Stomatology,
Sichuan University, State Key Laboratory of Oral Diseases, Chengdu, China. 4Dental Public Health, Faculty of Dentistry, The University of
Hong Kong, Hong Kong, China. 5Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University,
State Key Laboratory of Oral Diseases, Chengdu, China
Contact address: Xuedong Zhou, Department of Operative Dentistry and Endodontics, West China Hospital of Stomatology, Sichuan
University, State Key Laboratory of Oral Diseases, No. 14, 3rd Section, Ren Min South Road, Chengdu, Sichuan, 610041, China.
[email protected].
Editorial group: Cochrane Oral Health Group.

Publication status and date: New, published in Issue 9, 2016.
Citation: Wang Y, Li C, Yuan H, Wong MCM, Zou J, Shi Z, Zhou X. Rubber dam isolation for restorative treatment in dental patients.
Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD009858. DOI: 10.1002/14651858.CD009858.pub2.
ABSTRACT
Background
Successful restorations in dental patients depend largely on the effective control of moisture and microbes during the procedure. The
rubber dam technique has been one of the most widely used isolation methods in dental restorative treatments. The evidence on the
effects of rubber dam usage on the longevity of dental restorations is conflicting. Therefore, it is important to summarise the available
evidence to determine the effects of this method.
Objectives
To assess the effects of rubber dam isolation compared with other types of isolation used for direct and indirect restorative treatments
in dental patients.
Search methods
We searched the following electronic databases: Cochrane Oral Health's Trials Register (searched 17 August 2016), Cochrane Central
Register of Controlled Trials (CENTRAL; 2016, Issue 7) in the Cochrane Library (searched 17 August 2016), MEDLINE Ovid (1946 to 17
August 2016), Embase Ovid (1980 to 17 August 2016), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science
Information database; 1982 to 17 August 2016), SciELO BIREME Virtual Health Library (1998 to 17 August 2016), Chinese BioMedical
Literature Database (CBM, in Chinese) (1978 to 30 August 2016), VIP (in Chinese) (1989 to 30 August 2016), and China National Knowledge
Infrastructure (CNKI, in Chinese) (1994 to 30 August 2016). We searched ClinicalTrials.gov and the World Health Organization International
Clinical Trials Registry Platform, OpenGrey and Sciencepaper Online (in Chinese) for ongoing trials. There were no restrictions on the
language or date of publication when searching the electronic databases.
Selection criteria
We included randomised controlled trials (including split-mouth trials) assessing the effects of rubber dam isolation for restorative
treatments in dental patients.
Data collection and analysis

Two review authors independently screened the results of the electronic searches, extracted data and assessed the risk of bias of the
included studies. We resolved disagreement by discussion.
Rubber dam isolation for restorative treatment in dental patients (Review) 1
Informed decisions.
Main results
We included four studies that analysed 1270 participants (among which 233 participants were lost to follow-up). All the included studies
were at high risk of bias. We excluded one trial from the analysis due to inconsistencies in the presented data.
The results indicated that dental restorations had a significantly higher survival rate in the rubber dam isolation group compared to the
cotton roll isolation group at six months in participants receiving composite restorative treatment of non-carious cervical lesions (risk ratio
(RR) 1.19, 95% confidence interval (CI) 1.04 to 1.37, very low-quality evidence). It also showed that the rubber dam group had a lower risk of
failure at two years in children undergoing proximal atraumatic restorative treatment in primary molars (hazard ratio (HR) 0.80, 95% CI 0.66
to 0.97, very low-quality evidence). One trial reported limited data showing that rubber dam usage during fissure sealing might shorten
the treatment time. None of the included studies mentioned adverse effects or reported the direct cost of the treatment, or the level of
patient acceptance/satisfaction. There was also no evidence evaluating the effects of rubber dam usage on the quality of the restorations.
Authors' conclusions
We found some very low-quality evidence, from single studies, suggesting that rubber dam usage in dental direct restorative treatments
may lead to a lower failure rate of the restorations, compared with the failure rate for cotton roll usage. Further high quality research
evaluating the effects of rubber dam usage on different types of restorative treatments is required.
PLAIN LANGUAGE SUMMARY
Does isolating the site of a dental restoration during treatment improve the performance of the restoration?
Review question
This review examined whether different isolation methods affect the performance of dental restorations.
Background
Restorative dental treatments are used to repair damage to teeth caused by tooth decay or accidents. Creating a physical barrier around a
treatment site to reduce contamination of the site with saliva is a common practice. Reducing the amount of saliva in the area may enable
the materials used for repair to bond together more effectively, improving the performance and reliability of the restoration. It may also
reduce exposure to bacteria in the mouth.
Two methods of creating a barrier are commonly used; either a rubber dam around the tooth or cotton rolls together with suction to remove
excess saliva. The rubber dam method involves using a sheet of latex in a frame. A small hole is made in the sheet and it is placed over
the tooth to be treated creating a barrier around it. Using a rubber dam can isolate the tooth from the rest of the person's mouth, which
allows the tooth to be repaired dry and with relatively less exposure to bacteria in the mouth. A common alternative method of isolation
of the tooth is the use of cotton rolls combined with the removal of excess saliva by suction. The evidence on the effects of rubber dam
usage versus cotton roll usage is conflicting.
Study characteristics
The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 17 August 2016. We included
four studies that evaluated 1037 participants, mostly children, who were undergoing different types of dental restorative treatments, using
materials which require effective moisture control to reduce failure rates. For example, fissure sealing, resin or composite fillings at the
gum margin, and proximal atraumatic restorative treatment in primary molars. All of the included studies compared the use of rubber dam
and cotton rolls as two different isolation methods.
Key results
There is some evidence to suggest that the use of a rubber dam may increase the survival time of dental restorations compared to the use
of cotton rolls as an isolation method.
The studies did not include possible side effects.
Quality of the evidence
The evidence presented is of very low quality due to the small amount of available studies, uncertain results and problems related to the
way in which the available studies were conducted.

Rubber dam isolation for restorative treatment in dental patients (Review)
SUMMARY OF FINDINGS
Summary of findings for the main comparison. Rubber dam versus cotton rolls for restorative treatment in dental patients
Library
Cochrane
Rubber dam versus cotton rolls for restorative treatment in dental patients
Patient or population: dental patients

Settings: China and Kenya
Intervention: rubber dam versus cotton rolls
Better health.
Informed decisions.
Trusted evidence.
Outcomes Illustrative compara- Relative No of Qual- Comments
tive risks* (95% CI) effect partici- ity of
(95% pants the evi-
As- Corre- CI) (stud- dence
sumed sponding ies) (GRADE)
risk risk
Cotton Rubber
rolls dam
Survival rate (6 765 per 910 per RR 1.19 162 ⊕⊝⊝⊝ There was weak evidence showing that the use of rubber dam might result in higher
months) 1000 1000 (1.04 to (1 study) very survival rate of the restorations compared to cotton rolls at 6 months' follow-up
assessed clin- (796 to 1.37) low 1
ically and radi- 1000) Weak evidence also indicating the usage of rubber dam might relatively increase the
ographically survival rate of restorations after 24 months' follow-up compared to cotton rolls (HR
Follow-up: mean 0.80, 95% CI 0.66 to 0.97; 559 participants; 1 study; very low-quality evidence)
6 months
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is
based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval; HR: hazard ratio; RR: risk ratio
GRADE Working Group grades of evidence
Cochrane Database of Systematic Reviews

High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1 Downgraded 3 times due to being a single study, at high risk of bias and for indirectness: the included study had high risk of bias and was only conducted in China or Kenya
population that may not be applicable in other populations.
3
Informed decisions.
BACKGROUND removing the rubber dam, in rare cases, may also impede the wide
use of rubber dam.
Description of the condition
A number of modifications of rubber dam techniques have been
Restorative dental treatments are used to repair damage to teeth described. John Mamoun suggested the use of a rubber dam with a
caused by caries or trauma. Direct restorative dental treatments custom prosthesis to achieve dry-field isolation of the distal molars
(commonly known as 'fillings') repair damage to the visible tooth, with short clinical crowns (Mamoun 2002). Also, the slit rubber dam
such as restorations using either amalgam or a resin composite technique used when preparing teeth for indirect restoration could
material. Indirect restorations are prepared outside the person's promote operating efficiency (Perrine 2005). Further developments
mouth, using a dental impression from the prepared tooth. in rubber dam technique are ongoing.
Examples of indirect restorations include inlays, onlays, crowns,
bridges and veneers. How the intervention might work
Successful restorations depend on a number of factors, but perhaps Creating a physical barrier around a treatment site to reduce
the most important ones are moisture and microbe control. contamination due to moisture and microbes is common practice
Excluding moisture and saliva from the tooth or root being restored in medical and dental procedures. Isolating the tooth to be
facilitates the bonding of the restorative material to the tooth and restored from the contamination of moisture or saliva in restoration
decreases the risk of infection or re-infection. Poor bonding or placement may promote the bonding of the restorative materials
secondary caries may compromise the success or longevity of the to the tooth, while rubber dam usage is mandatory for endodontics
restoration, or both. for reasons of safety and cross infection control. The use of a rubber
dam in restorative dentistry has the added advantage of providing
Description of the intervention the dentist with a broader work surface which also traps small
pieces of debris and treatment solutions protecting the person
A common method of isolation and moisture control in restorative
from inadvertently swallowing these. When rubber dams are used
dentistry is the use of cotton rolls combined with aspiration by
in association with amalgam restorations, they may reduce the
saliva ejector. This technique is widely available and low cost, but
person's exposure to potentially harmful adverse effects of mercury
has the disadvantage that the dentist is required to replace sodden
ingestion (Halbach 2008; Kremers 1999).
cotton rolls frequently during the treatment to keep the operative
field dry. Why it is important to do this review
An alternative method of isolation of the tooth undergoing Both rubber dam and cotton rolls are currently used in dentistry
restorative treatment is a rubber dam, an isolation method, to isolate the treatment field and to exclude moisture. There are
introduced to the dental profession by Dr Sanford C Barnum on advantages and disadvantages associated with each method from
15 March 1864 (Elderton 1971a; Elderton 1971b; Elderton 1971c). the different points of view of person and dentist. Moreover, several
Since then, many researchers have improved its application and randomised controlled trials have been conducted to determine
it is now a frequently used, practical alternative to cotton balls whether the use of a rubber dam for restorative treatments
(Bhuva 2008; Carrotte 2000; Carrotte 2004; Reuter 1983). A rubber influences the treatment outcomes (Carvalho 2010; Kemoli 2010;
dam is usually a small sheet of latex (though non-latex versions are Ma 2012). However, the results from these trials appear to be
available) placed in a frame. A small hole is made in the sheet and conflicting. The purpose of this systematic review is to evaluate
placed over the tooth to be treated. The rubber dam is held on to the the effectiveness of the rubber dam as an isolation and moisture
tooth being restored by means of a small clamp. This isolates the reduction technique used in restorative dentistry, together with
tooth from the rest of the person's mouth, which keeps the tooth to any adverse or negative effects. This information will then be
be restored dry and relatively less exposed to intraoral bacteria. available so that both dentists and their patients can make
informed decisions about the benefits and possible negative effects
Potential advantages of the use of a rubber dam include superior of different isolation and moisture control techniques to be used for
isolation of the tooth to be treated from the saliva in the mouth specific dental restorations.
(Cochran 1989), providing the dentist with improved visibility,
reduced mirror fogging, enhanced visual contrast, soft tissue OBJECTIVES
retraction (Reid 1991), protection of the person by preventing
ingestion or aspiration of instruments (Susini 2007; Tiwana 2004), To assess the effects of rubber dam isolation compared with other
materials, or irrigant (Cohen 1987), and preventing oral soft types of isolation used for direct and indirect restorative treatments
tissues from contact with irritating or harmful materials used in dental patients.
during operative procedures, such as phosphoric acids or sodium
hypochlorite (Lynch 2003). There is also a reduction in the risk of METHODS
cross-infection in the dental practice by decreasing the microbial
content of splatters and air turbine aerosols produced during Criteria for considering studies for this review
dental treatment (Harrel 2004). Types of studies
However, there are real and perceived negative effects to the All randomised controlled trials or quasi-randomised controlled
use of rubber dams. Most often cited are concerns over patient trials (including split-mouth/cross-over studies).
acceptance, time needed for application, cost of materials and
equipment, insufficient training and inconvenience (Hill 2008;
Koshy 2002; Stewardson 2002). Latex allergy, rubber dam clamp
fracture (Sutton 1996), and damage to the mucosa when placing or
Informed decisions.
Types of participants • Cochrane Central Register of Controlled Trials (CENTRAL; 2016,

Issue 7) in the Cochrane Library (searched 17 August 2016)
People undergoing any type of direct or indirect restorative
(Appendix 2);
treatment. There were no restrictions of age or gender.
• MEDLINE Ovid (1946 to 17 August 2016) (Appendix 3);
Restorative treatment included direct anterior restorations, direct • Embase Ovid (1980 to 17 August 2016) (Appendix 4);
posterior restorations, inlays, onlays, veneers, crowns, etc. • LILACS BIREME Virtual Health Library (Latin American and
Caribbean Health Science Information database; 1982 to 17
Types of interventions
August 2016) (Appendix 5);
The intervention group received a rubber dam for isolation and • SciELO BIREME Virtual Health Library (Scientific Electronic
moisture control, either alone or combined with other active Library Online; 1998 to 17 August 2016) (Appendix 6);
treatment (such as saliva aspiration). The comparison (control) • Chinese BioMedical Literature Database (CBM, in Chinese) (1978
group received an alternative method of isolation and moisture to 30 August 2016) (Appendix 7);
control (such as cotton rolls) with or without the same active
• VIP (in Chinese, 1989 to 30 August 2016) (Appendix 8);
treatment as in the intervention group.
• China National Knowledge Infrastructure (CNKI, in Chinese)
Types of outcome measures (1994 to 30 August 2016) (Appendix 9).
Primary outcomes Searching other resources
• Survival rate of the restorations at 6 months, 1, 2, 5 and 10 years Searching for unpublished studies and ongoing studies
after restorative treatments. Survival means the restorations
were still correctly present or having only a slight wear or defect We searched the following sources for unpublished and ongoing
at the margin less than 0.5 mm in depth when assessed. If the studies:
restorations were either completely lost, or were fractured with
• US National Institutes of Health Ongoing Trials Register
defects 0.5 mm in depth or greater, had secondary caries or
ClinicalTrials.gov (clinicaltrials.gov/; searched 17 August 2016)
inflammation of the pulp, any of these situations was labelled as
(Appendix 10);
treatment failure.
• World Health Organization International Clinical Trials Registry
• Adverse events. Any reported adverse events related to any
Platform (apps.who.int/trialsearch; searched 17 August 2016)
of the active interventions during the treatment phase. These
(Appendix 10);
included events affecting the operator or the patient (e.g.
damage to skin or mucosa, allergic reactions to latex). • OpenGrey (1980 to 17 August 2016) (Appendix 11);
• Sciencepaper Online (in Chinese, to 30 August 2016) (Appendix
Secondary outcomes 12).
• Clinical evaluation of restoration's quality, including colour Handsearching
match, cavo-surface marginal discolouration, anatomic form,
marginal adaptation and caries, which were assessed at We handsearched the following journals:
baseline (i.e. within one month following the placement) as
well as 6 months, 1, 2, 5 and 10 years of subsequent recalls. • Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and
The evaluation should be based upon the US Public Health Endodontology (1995 to October 2015);
Service (USPHS) criteria and its evolution (Hickel 2007), which • Journal of Endodontics (1975 to October 2015);
had specific clinical criteria followed for the assessment of each • International Endodontic Journal (1967 to October 2015);
category. • Caries Research (1967 to October 2015);
• Costs: the direct cost of the treatment, the time needed to • Journal of Dental Research (1970 to October 2015);
accomplish the treatment. • International Journal of Oral Science (2009 to October 2015);
• Participant acceptance/satisfaction. Participants expressed • Dental Traumatology (1985 to October 2015);
satisfaction with the procedure using any validated instrument.
• Australian Endodontic Journal (1967 to October 2015).
Search methods for identification of studies
In addition, we explored the following Chinese dental journals:
For the identification of studies included or considered for this
review, we developed detailed search strategies for each database • Chinese Journal of Stomatology (2005 to October 2015);
searched. We based these on the search strategy developed for • West China Journal of Stomatology (2005 to October 2015);
MEDLINE but revised appropriately for each database to take • Journal of International Stomatology (2005 to October 2015);
account of differences in controlled vocabulary and syntax rules. • Journal of Clinical Stomatology (2005 to October 2015);
There were no language restrictions in the searches. We translated
• Journal of Practical Stomatology (2005 to October 2015);
papers when necessary.
• Journal of Comprehensive Stomatology (2005 to October 2015);
Electronic searches • Journal of Modern Stomatology (2005 to October 2015);
The search included the following databases: • Chinese Journal of Conservative Dentistry (2005 to October 2015);
• Chinese Journal of Dental Prevention and Treatment (2005 to
• Cochrane Oral Health's Trials Register (searched 17 August 2016) October 2015).
(Appendix 1);

Informed decisions.
Reference lists and contacts • Blinding of participants and personnel (performance bias):
performance bias due to knowledge of the allocated
We screened the references of the included articles for studies. We
interventions by participants and personnel during the study.
contacted authors and experts in the field to identify unpublished
randomised controlled trials. • Blinding of outcome assessment (detection bias): detection bias
due to knowledge of the allocated interventions by outcome
Data collection and analysis assessors.
• Incomplete outcome data (attrition bias): attrition bias due to
Two review authors (Yan Wang (YW), He Yuan (HY)) independently
amount, nature or handling of incomplete outcome data.
selected studies, extracted and managed data, and assessed risk of
bias. We resolved any differences of opinion by discussion. • Selective reporting (reporting bias): reporting bias due to
selective outcome reporting.
Selection of studies • Other bias: bias due to problems not covered elsewhere in the
table.
We used a two-step process to identify studies to be included in
this review. We screened titles and abstracts from the electronic We categorised the overall risk of bias according to Additional Table
searches to identify studies which may have met the inclusion 1 and summarised the 'Risk of bias' graphically.
criteria for this review. We obtained full-text copies of all apparently
eligible studies and two review authors evaluated these further in Measures of treatment effect
detail to identify those studies which actually met all the inclusion
For the primary outcome of survival/success rate of the restorative
criteria. We recorded those studies which did not meet the inclusion
treatment, we expressed the measure of the treatment effect as
criteria in the excluded studies section of the review and noted the
a hazard ratio (HR) or risk ratio (RR) with 95% confidence interval
reason for exclusion in the Characteristics of excluded studies table.
(CI). If the studies did not quote HRs, we calculated the log HRs and
Data extraction and management the standard errors (SE) from the available summary statistics or
Kaplan-Meier curves according to the methods proposed by Parmar
We designed and piloted a data extraction form on two and colleagues (Parmar 1998), or requested the data from study
included studies. The data extraction form included the following authors. For the primary outcome of incidence of adverse events,
information. we used the RR and 95% CIs to estimate the treatment effect.
• Article title, publication time, journal, reviewer ID. For the secondary outcomes, we used RR and 95% CIs for
• Inclusion re-evaluation. dichotomous data and mean difference (MD) and 95% CIs for
• Types of studies: methods of randomisation, methods of continuous data.
allocation concealment, methods of blinding, location of the
study, number of centres, time frame, source of funding. Unit of analysis issues
• Types of participants: source of participants, types of disease, The unit of analysis was the participant.
diagnostic criteria, age, sex, eligibility criteria, numbers of
participants randomised to each group, number evaluated in Cross-over/split-mouth trials
each group. We assessed carry-over or carry-across effect of designs if we
• Types of intervention and comparison: details of the treatments considered them a problem. For an ideal study (which reported MD
received in the intervention and comparison groups, together and standard deviation (SD) of both groups and the MD together
with the type of restoration procedure and any co-interventions with SD/SE between the two groups), we calculated the intracluster
used. correlation coefficient (ICC); if more than one ideal study existed, we
• Types of outcome measures: outcome, time point that the calculated a mean ICC. We used this ICC in the calculation of MD and
outcome was recorded, exact statistics. SD/SE of the other similar cross-over/split-mouth studies. If there
was no ideal study, we assumed the ICC was 0.5 (Higgins 2011).
Assessment of risk of bias in included studies
Trials with multiple intervention arms
The review authors assessed the risk of bias for each included study
in each of seven domains using the 'Risk of bias' tool as described For randomised controlled trials with multiple treatment arms,
in Chapter 8 of the Cochrane Handbook for Systematic Reviews there were two steps to deal with this problem. First, we tried
of Interventions (Higgins 2011). For each domain, we presented to combine treatment arms, or we analysed the most relevant
explanations and judged them as low risk, unclear risk and high treatment and controls groups. For such trials, we collected the
risk. The domains and explanations were as follows. data in all the groups and recorded details in the Characteristics of
included studies table.
• Random sequence generation (selection bias): selection
bias (biased allocation to interventions) due to inadequate Dealing with missing data
generation of a randomised sequence.
Where information about trial procedures was incomplete or
• Allocation concealment (selection bias): selection bias (biased unclear in a trial report, or data were missing or incomplete, the
allocation to interventions) due to inadequate concealment of review authors attempted to contact the trial authors to obtain
the allocation sequence from those involved in the enrolment clarification. Where we could not obtain missing data, we did not
and assignment of participants. include the trial in the meta-analysis but described the results
narratively. Where SDs were missing from continuous outcome
data, we attempted to calculate these based on other available
Informed decisions.
data (e.g. CIs, SEs, t values, P values, F values), as discussed in the • types of adhesives.
Cochrane Handbook for Systematic Reviews of Interventions (Higgins
2011). Due to the small number of eligible studies and a lack of suitable
data from the included studies, we were unable to do subgroup
Assessment of heterogeneity analyses; however, we will consider carrying this out if more eligible
studies are included in future updates of this review.
We considered two types of heterogeneity.
Sensitivity analysis
Clinical heterogeneity
We planned to perform a sensitivity analysis to detect the stability
We judged clinical heterogeneity from the similarity between the
of the outcomes. If there had been a sufficient number of included
types of participants, interventions and outcome measures in each
trials, we would have based sensitivity analysis on risk of bias (low
trial.
risk of bias versus high or unclear risk of bias).
Statistical heterogeneity
Presentation of main results
We calculated statistical heterogeneity through the Chi2 test and We developed a 'Summary of findings' table for the reported
measured the effect using the I2 statistic or P value (P value < 0.1 primary outcomes of this review using GRADEproGDT software
indicated statistically significant heterogeneity). The classification (GRADEproGDT). We assessed the quality of the body of evidence
of statistical heterogeneity was as follows. with reference to the overall risk of bias of the included studies,
the directness of the evidence, the inconsistency of the results,
• 0% to 40% implied slight heterogeneity.
the precision of the estimates, the risk of publication bias, the
• 30% to 60% moderate heterogeneity. magnitude of the effect and whether there was evidence of a dose
• 50% to 90% substantial heterogeneity. response. GRADE categorises the quality of the body of evidence for
• 75% to 100% considerable heterogeneity. each of the primary outcomes as high, moderate, low or very low
(Atkins 2004; Guyatt 2008; Higgins 2011).
Assessment of reporting biases
RESULTS
We planned to report bias using a funnel plot if the number of
included studies had exceeded 10. The asymmetry of the funnel Description of studies
plot would indicate a possibility of reporting bias. Further detection
would use Begg's test (Begg 1994) for dichotomous data and See Characteristics of included studies and Characteristics of
Egger's test (Egger 1997) for continuous data. excluded studies tables.
Data synthesis Results of the search

We planned to perform meta-analyses only when there were little The electronic searches retrieved 1213 references, which reduced
clinical heterogeneity and statistical heterogeneity (I2 less than to 781 after de-duplication. Handsearching of the journals did
75%). If the number of studies in one outcome did not exceed four, not identify any additional studies. After reviewing the titles and
we planned to use the fixed-effect model; otherwise, we planned to abstracts, we disregarded 762 references that did not match our
use the random-effects model. criteria and were clearly ineligible. We obtained the full-text copies
of the remaining 19 studies for further evaluation. We classified
Subgroup analysis and investigation of heterogeneity one study into 'studies awaiting classification' as we were waiting
responses from the authors on the details of the method of
If the number of studies in one outcome exceeded 10, we planned to
randomisation used, preformation of allocation concealment and
use meta-regression to detect clinical heterogeneity (using STATA
the funding sources (Alhareky 2014). We excluded nine studies (13
11.0). If there was clinical heterogeneity, we planned to perform
references). Finally, four studies (five references), including one
subgroup analysis of the following:
Chinese study and three English studies, were eligible for inclusion
• types of restorative treatments; (Ammann 2013; Carvalho 2010; Kemoli 2010; Ma 2012).
• age of the participants; We have presented this process as a flow chart in Figure 1.
• location of the restoration (anterior/posterior teeth);

Informed decisions.
Figure 1. Study flow diagram.
Included studies Characteristics of the trial designs and settings

This review included four randomised controlled trials (RCTs), All of the included studies used a parallel design (Ammann 2013;
which were published between 2010 and 2013 (Ammann 2013; Carvalho 2010; Kemoli 2010; Ma 2012). The studies were conducted
Carvalho 2010; Kemoli 2010; Ma 2012). See Characteristics of in Germany (Ammann 2013), Brazil (Carvalho 2010), Kenya (Kemoli
included studies table for details of the included studies. 2010) and China (Ma 2012). One study was carried out in a private
dental clinic setting (Ammann 2013), one in a dental hospital setting

Informed decisions.
(Ma 2012), and two in a school setting (Carvalho 2010; Kemoli 2010). "survival or failure of the restorations". Carvalho 2010 and Kemoli
One study performed a sample size calculation; however, the study 2010 defined "survival of the restorations" as the restorations being
did not mention the method used (Kemoli 2010). The other three present with marginal defects 0.5 mm or less in depth and general
studies did not mention sample size calculations (Ammann 2013; wear 0.5 mm or less in depth at the deepest point. Ma 2012 defined
Carvalho 2010; Ma 2012). Two studies did not state their funding "failure" as the restoration being absent at the time of evaluation.
sources (Ma 2012), and one study stated that they received both None of the three studies reported adverse effects. Ammann 2013
industry and non-industry funding (Kemoli 2010). The remaining did not report survival rate or adverse effects.
studies stated that they received industry funding (Ammann 2013)
or non-industry funding (Carvalho 2010). None of the included studies evaluated the quality of the
restorations, the direct cost of the treatment or the level of
Characteristics of the participants participant acceptance/satisfaction. Ammann 2013 evaluated the
treatment time when using rubber dam or cotton rolls as the
The trials included 1270 participants (among which 233
isolation method in fissure sealing.
participants were lost to follow-up) with different age ranges and
receiving various restorative treatments. Ammann 2013 included Excluded studies
72 children aged 5.9 to 11.9 years who undertook fissure sealing
of premolars or molars. Ma 2012 studied 162 participants (162 We listed all the excluded studies and the reasons for their exclusion
teeth) with non-carious cervical lesions (NCCLs) receiving resin in the Characteristics of excluded studies table.
composite restoration, without mentioning the age range and sex
Six studies were controlled clinical trials (CCT) (Ganss 1999; Huth
ratio. Two studies included children undertaking proximal primary
2004; Sabbagh 2011; Smales 1993; Straffon 1985; van Dijken 1987).
atraumatic restorative treatment (ART) restorations in primary
Three studies used either an inappropriate study design or an
molars. These two studies included 804 children aged six to eight
inappropriate statistical analysis (Daudt 2013; Fontes 2009; Raskin
years (Kemoli 2010), and 232 children aged six to seven years
2000). Daudt 2013 and Raskin 2000 performed randomisation and
(Carvalho 2010). All the participants of these included studies
analysis at the tooth level without accounting for the clustering
received direct dental restorative treatments.
effect of teeth within individual participants. For Fontes 2009, the
Characteristics of the interventions study claimed to be performed using a split-mouth design, but it
was not carried out it in an appropriate way.
The active intervention in each of the included trials was rubber
dam isolation in dental restorative treatments. All of the included Risk of bias in included studies
trials used a comparison group of cotton rolls as the alternative
isolation method. All of the included studies were at high risk of bias overall, based
on a judgement of high risk of bias for two domains (Ammann 2013;
Characteristics of the outcome measures Carvalho 2010; Kemoli 2010), or one domain (Ma 2012).
None of the included studies reported both primary outcomes. Details of the assessments made of these studies are available in
Three studies reported the survival rate or failure rate of the the 'Risk of bias' section of the Characteristics of included studies
restorations (Additional Table 2) (Carvalho 2010; Kemoli 2010; Ma table and in the 'Risk of bias' graph (Figure 2) and 'Risk of bias'
2012). There was variability between the studies in their criteria for summary (Figure 3).
Figure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages
across all included studies.

Informed decisions.
Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Allocation Blinding
Method of randomisation We judged all of the included studies at high risk of performance
bias, because the types of interventions did not permit blinding of
Ammann 2013, Carvalho 2010, and Kemoli 2010 clearly stated
the operators or the participants (Ammann 2013; Carvalho 2010;
the methods of randomisation used in the references. Thus, we
Kemoli 2010; Ma 2012).
assessed these three studies at low risk of bias. We judged Ma 2012
at unclear risk of bias in its method of randomisation, because there We assessed two studies at low risk of detection bias (Carvalho
was insufficient information to make a clear judgement. 2010; Kemoli 2010). In Carvalho 2010, they explicitly reported the
blinding of outcome assessors; and in Kemoli 2010, as the authors
Allocation concealment
clearly stated that the outcome assessors were calibrated and were
We were unable to make a judgement of high or low risk of bias not the operators, we believed that the outcome assessors had high
for allocation concealment as it was not adequately reported in the possibility of being blinded. The remaining studies were at unclear
included studies (Ammann 2013; Carvalho 2010; Kemoli 2010; Ma risk of bias in the blinding of outcome assessment, because they
2012). did not mention the blinding of outcome assessors (Ammann 2013;
Ma 2012).

Informed decisions.
Incomplete outcome data reported the cumulative survival rate of dental restorations at 6, 12,
18 and 24 months. However, the number of restorations reported to
We judged attrition bias as being low in two studies, because they
have been performed at the start of the evaluation period and the
reported no losses to follow-up (Ammann 2013; Ma 2012). Kemoli
number of restorations failed at the end of the evaluation period
2010 reported that 19.1% of the participants were lost to follow-up,
were not consistent with the reported survival rate. Due to these
but did not provide information about the distribution of attrition
inconsistencies, we were unable to include the data of this study
between treatment groups. Thus, we assessed this study as having
in our analyses. Kemoli 2010 found a significant difference in the
an unclear risk of bias for this domain. We also judged Carvalho
survival rate of dental restorations was observed at two years in
2010 at unclear risk of bias, because the reasons for the exclusions
favour of rubber dam usage (hazard ratio (HR) 0.80, 95% CI 0.66 to
of participants were not fully described even though the number
0.97, 559 participants, very low-quality evidence) (Analysis 1.2).
of exclusions in each group was comparable (14.7% in the control
group and 18.5% in the rubber dam group). The cut-off points used Adverse events
for deciding the risk of attrition bias may be subjective; therefore,
readers of this review could interpret the risk of bias for this domain None of the included studies reported adverse events.
differently.
Secondary outcomes
Selective reporting Clinical evaluation of restoration's quality
We considered two studies as being at high risk of bias in reporting None of the included studies evaluated the quality of the
data (Ammann 2013; Carvalho 2010). In Ammann 2013, the authors restorations.
did not fully report the data on the treatment time in fissure sealing;
and in Carvalho 2010, as the survival/failure rate was not consistent Costs
with the number of restorations considered as success or failure One study, at high risk of bias evaluating 72 children, reported
presented, we were unable to use the data for analysis. We assessed 12.4% less time (108 seconds) needed to accomplish fissure sealing
the studies of Kemoli 2010 and Ma 2012 at low risk of bias for using rubber dam compared to using cotton rolls as the isolation
reporting bias, because they fully reported all the prespecified method (Ammann 2013). None of the included studies reported the
outcomes. direct cost of treatment.
Other potential sources of bias Participant acceptance/satisfaction
Ma 2012 did not report the characteristics of participants to allow None of the included studies reported the level of participant
an assessment of the comparability of the treatment and control acceptance/satisfaction.
groups at baseline. Thus, we judged this study at unclear risk of
bias for this domain. We considered Ammann 2013 and Carvalho DISCUSSION
2010 at low risk of bias for other potential sources of bias, because
they reported the comparability of the treatment and control Summary of main results
groups at baseline. In Kemoli 2010, there was a substantial baseline
Four studies met the inclusion criteria for this review, and all of
imbalance in the dental arch between rubber dam and cotton roll
these studies evaluated the effects of rubber dam versus cotton
isolation groups, which might have influenced the performance of
roll isolation methods on the direct restorative treatments in
the restorations, so we assessed this study at high risk of bias for
dental patients, including fissure sealing in permanent premolars
other potential sources of bias.
or molars, proximal atraumatic restorative treatment (ART) in
Effects of interventions primary molars and composite resin restoration of non-carious
cervical lesions (NCCLs) in permanent teeth. We assessed the
See: Summary of findings for the main comparison Rubber dam quality of the body of evidence based upon the GRADE approach,
versus cotton rolls for restorative treatment in dental patients which takes into account the risk of bias of the included studies,
the directness of the evidence, the consistency of the results
Rubber dam versus cotton rolls (heterogeneity), the precision of the effect estimates and the risk of
Four studies, at high risk of bias, compared rubber dam isolation publication bias (GRADE 2004). We have provided a summary of this
method with cotton rolls as the alternative isolation method, and quality assessment for survival rates at six months and two years
evaluated 1037 participants. (Summary of findings for the main comparison).
Primary outcomes There was very low-quality evidence, from single studies, indicating
that rubber dam isolation may favour a higher survival rate or
Survival rate of the restorations a lower loss rate of restorations during dental direct restorative
Three studies reported the survival/loss rate of the restorations treatments.
(Additional Table 2). One study reported the loss rate of the
restorations (Ma 2012). The analysis indicated that rubber dam • Rubber dam compared with cotton rolls in resin composite
usage resulted in a higher retention rate of restorations in restorative treatments of NCCLs (very low-quality evidence) (Ma
participants with NCCLs receiving resin composite restorative 2012).
treatment at six months (risk ratio (RR) 1.19, 95% confidence • Rubber dam compared with cotton rolls in proximal ART
interval (CI) 1.04 to 1.37, 162 participants, very low-quality restorative treatments in primary molars (very low-quality
evidence) (Analysis 1.1). Two studies reported the survival rates evidence) (Kemoli 2010).
of the restoration (Carvalho 2010; Kemoli 2010). Carvalho 2010

Informed decisions.
We did not analyse the data for rubber dam versus cotton rolls in only included studies evaluating the effects of the operatory field
Carvalho 2010, because we found inconsistencies of reported data. isolation techniques (rubber dam or cotton rolls/saliva ejector) on
Ammann 2013 did not evaluate the survival rate of fissure sealants. the longevity of direct restorations performed with tooth-coloured
None of the included studies reported adverse events. materials in primary or permanent posterior teeth, and having a
follow-up period of at least 12 months. Moreover, the Cajazeira
Overall completeness and applicability of evidence 2014 review included two studies that we excluded: Huth 2004,
which we excluded since randomised allocation of participants was
The identified studies in the review did not address the
not performed between the two isolation groups in the study, and
objectives of the review sufficiently. Four studies were eligible for
Raskin 2000, which we excluded due to inappropriate statistical
inclusion, and they only investigated participants receiving fissure
analysis (randomisation and analysis at tooth level without
sealing, resin composite restorations of NCCLs and proximal ART
accounting for the clustering effect of teeth within participants).
restorative treatments. We found no eligible randomised controlled
They finally included four studies into the analysis (Carvalho 2010;
trials (RCTs) of participants receiving other types of restorative
Huth 2004; Kemoli 2010; Raskin 2000), and concluded that the use
treatments such as inlays, onlays, etc. Furthermore, none of the
of rubber dam might not influence the longevity of restorations in
included studies fully reported the outcomes and the evidence
comparison to using cotton rolls/saliva ejector.
was incomplete regarding the outcomes. There were no included
studies evaluating the quality of the restorations or reporting
AUTHORS' CONCLUSIONS
adverse effects, the direct cost of the treatment, or the level of
participant acceptance/satisfaction, which are important aspects Implications for practice
in rubber dam usage (Hill 2008; Koshy 2002; Stewardson 2002).
Although three of the included studies reported the survival/loss We found some very low-quality evidence, from single studies,
rate, we could not pool the outcomes to address this primary suggesting that rubber dam usage in dental direct restorative
outcome due to inconsistent data presentation, differences in the treatments may lead to a higher survival rate of the restorations.
restorative treatments carried out, different follow-up time points, The effect estimate should be interpreted with caution due to a high
or different criteria used for the definition of 'survival/failure' risk of bias in the analysed studies, the small number of included
among them. studies and that the type of restorative treatments varied among
studies. This review found no evidence to support or refute any
Quality of the evidence adverse effects that the rubber dam isolation method may have on
patients.
The body of evidence that we identified did not allow for
robust conclusions about the effects of rubber dam isolation for Although there was no robust evidence to favour rubber dam
restorative treatment to be made. We included four studies, which usage in improving the survival rate of restorations, this does
analysed 1037 participants. We excluded one study from analysis not mean that rubber dam usage is not important during
due to inconsistencies in the presented data (Carvalho 2010). restorative treatments, since the clinical decision is not solely
The remaining three studies were at high risk of bias (Ammann based upon its ability to reduce failure rate of restorations.
2013; Kemoli 2010; Ma 2012). When such risk of bias issues were The use of rubber dam still has numerous advantages, such as
considered alongside the fact that the study in each comparison/ preventing accidental swallowing of restorative instruments or
outcome was a single small study (leading to serious imprecision), tooth fragments, protecting soft tissues from sharp instruments, or
this resulted in us rating the evidence as very low quality. These helping in behaviour management in children. Clinicians still need
GRADE ratings can be interpreted as a lack of confidence in the to practice rubber dam placement, and never using a rubber dam
effect estimates. Further research is likely to change the estimates would not be an acceptable approach.
and our confidence in them.
Implications for research
Potential biases in the review process
The fact that we are unable to make a robust conclusion on the
We searched multiple databases with no language restrictions, effect of using rubber dam isolation during restorative treatments
intending to limit bias by including all relevant studies. However, in dental patients demonstrates that more randomised controlled
we did not include all of the included studies into the analysis, trials with longer follow-up periods are needed. In particular, we
and this could introduce bias into the review as it may distort our identified no studies that investigated the effects of the isolation
overall view of the effects of the rubber dam isolation method. methods on the performance of indirect restorations. Further
Our subjective assessments that a loss to follow-up of more than properly designed high quality research is required, as we excluded
20% constitutes a high attrition rate could also be interpreted as a few studies due to inappropriate statistical analysis, such as
bias by some readers. However, we have presented all the related performing randomisation and analysis at tooth level without
information, rationales for the method used, and our assessments accounting for the clustering effect of teeth within participants.
with the intention of transparency and to allow the readers to reach Studies should report the survival rate of restorations and perform
their own conclusion. clinical evaluation of the quality of the restorations based upon
US Public Health Service criteria. Adverse effects, participant
Agreements and disagreements with other studies or acceptance/satisfaction and the direct cost of the treatment should
reviews also be clearly reported at the participant level per group.
To our knowledge, one systematic review has studied the influence
of different operatory field isolation techniques on the longevity
of dental restorations (Cajazeira 2014). Their inclusion criteria
differed from the inclusion criteria of this review in that they

Informed decisions.
ACKNOWLEDGEMENTS Trevor Burke), and Consumer Co-ordinator (Ruth Floate) for their
help in conducting this systematic review. We would also like
We would like to thank Cochrane Oral Health editorial team, to thank Anne Littlewood for designing the search strategy and
external referees (Alison Qualtrough, Patrick Sequeira-Byron and doing databases searches, and thank Janet Lear for helping with
obtaining the full-text articles.

Informed decisions.
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* Indicates the major publication for the study
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Ammann 2013
Methods Design: parallel-group RCT
Recruitment period: not stated
Administration setting: private dental clinic
Country: Germany
Funding source: Dentsply DeTrey, Konstanz, Germany
Participants Number of participants randomised: 72 (rubber dam: 34; cotton rolls: 38)
Randomisation unit: participant
Age: 5.9 to 16.9 years, mean age 11.1 years
Sex: 23 boys, 49 girls
Inclusion criteria:
• aged 6 to 16 years
• given indication for fissure sealing
Exclusion criteria:
• participation in other studies evaluating parameters of stress

• not totally erupted teeth to seal
• lack of compliance
• no agreement from the guardians
• presence of fixed orthodontic appliances
• signs of opacity and brown discolouration of the tooth to be sealed
• psychotropic medication or cardiovascular drugs
• already sealed teeth

Informed decisions.
Ammann 2013 (Continued)

• present disease (cold)
• allergic reactions to used materials
Restorative treatments received: fissure sealing in premolar/molar
Number of participants evaluated: 72 (rubber dam: 34; cotton rolls: 38)
Withdrawals/loss to follow-up: no withdrawals
Interventions Number of groups: 2
Intervention: rubber dam: "A suitable rubber dam clamp (Ivoryò; Sigma Dental Systems, Handewitt,
Germany) was selected and applied. Afterwards, the rubber dam was placed over the clamp. Several
teeth were included in the rubber dam in cases involving premolars, whereas for molars only the treat-
ed tooth was isolated"
Control: cotton rolls: "The cotton rolls were positioned on the buccal and lingual region of the tooth to
be sealed and were fixed by the operator's index finger and middle finger. Additionally, a saliva ejector
was placed on the lingual side"
Outcomes Outcomes: treatment time
Notes Adverse events: not stated
No details on sample size or power calculation were provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- Low risk Quote: "72 subjects successfully took part in the study and were divided into
tion (selection bias) two parallel groups by a dental assistant by drawing sealed lots (test n = 34;
control n = 38)"
Comment: method stated and appropriate
Allocation concealment Unclear risk Not stated

(selection bias)
Comment: insufficient information reported to make a judgement
Blinding of participants High risk Comment: the operators and the participants could not be blinded
and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- Unclear risk Not stated

sessment (detection bias)
All outcomes Comment: insufficient information reported to make a judgement
Incomplete outcome data Low risk Comment: no withdrawals

(attrition bias)
All outcomes
Selective reporting (re- High risk Quote: "The time needed to finish the fissure sealing treatment was 12.4% (108
porting bias) s [seconds]) less when using rubber dam (P < 0.05)"
Comment: insufficient information reported to use the data in the analysis
Other bias Low risk Comparable groups at baseline (age, gender, type of teeth treated)

Informed decisions.
Carvalho 2010
Administration setting: schools
Country: Brazil
Funding source: the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Participants Number of participants randomised: 232; 232 teeth (rubber dam: 115; cotton rolls: 117)
Randomisation unit: participant/tooth
Age: 6 to 7 years, mean age 6.3 years
Inclusion criteria:
• proximal lesions having access to ART hand instruments, with a mesio-distal maximum dimension of
1 mm and a buccal-lingual maximum dimension of 2 mm length, measured on the occlusal surface
using a periodontal probe
• lesions with unimpaired adjacent tooth
Exclusion criteria:
• cavitated carious lesions having pulpal involvement, swelling, fistula or pain
Restorative treatments received: proximal ART restorations in primary molar
Number of participants evaluated: 155 (rubber dam: 72 teeth; cotton rolls: 83 teeth)
Withdrawals/loss to follow-up: 77 children in total. 48 children were unavailable at the time of assess-
ment. 29 children lost their teeth due to exfoliation or extraction
Intervention: rubber dam: "For the experiment group, a rubber dam was used, fixed with a clamp on
the adjacent distal tooth without local anaesthesia"
Control: cotton rolls: "New cotton rolls were placed on both sides of the molar without local anaesthe-
sia"
Outcomes Outcomes: failure rate/cumulative survival rate of restorations
Time points: 6, 12, 18 and 24 months after restoration placement
Diagnostic criteria: restorations assessed according to the following criteria:
• successful treatment: when it was still present and correct or having only a slight wear or defect at
the margin < 0.5 mm in depth
• treatment failures: when the restorations were either completely lost, or were fractured with defects
≥ 0.5 mm in depth, had secondary caries, or inflammation of the pulp
• lost to follow-up: when the children who were not found at the time of assessment, or when the teeth
were lost to exfoliation or extraction

Informed decisions.
Carvalho 2010 (Continued)

No details on sample size or power calculation provided
The survival/failure rate was not consistent with the number of restorations considered as success or
failure presented in table 1 of the report. We were unable to use the data in the analysis
Risk of bias
Random sequence genera- Low risk Quote: "Each child was individually allocated into a group by the use of gener-
tion (selection bias) ated random numbers, and no restrictions were considered"
Allocation concealment Unclear risk Quote: "Each child was individually allocated into a group by the use of gen-
(selection bias) erated random numbers, and no restrictions were considered. The group in
charge of making the restorations or those who assessed the restorations did
not have access to the randomizations procedure. All children were allocated
into the respective group before the restorations were made"
Comment: sequence allocation was not adequately described
Blinding of participants High risk Comment: the operators and the participants could not be blinded
mance bias)
All outcomes
Blinding of outcome as- Low risk Quote: "These examiners were blinded to the exposure categories. In other
sessment (detection bias) words, at the time of examination of the restoration, the examiners did not
All outcomes know to which group the child belonged to"
Comment: examiners were blinded
Incomplete outcome data Unclear risk Quote: "Throughout the study, a total of 48 (20.7%) children were considered
(attrition bias) as lost to follow-up. Others eventually lost their teeth due to exfoliation or
All outcomes extraction. Due to such reasons, a total of 77 restorations (33.2%) were cen-
sored (lost to follow-up), where 34 (14.7%) were from the control group and 43
(18.5%) from the rubber dam group (χ2 [Chi2] = 1.82; df [degrees of freedom] =
1; P = 0.18)"
Comment: loss to follow-up was high (overall 33.2%) and reasons for loss to
follow-up (20.7%) were not explicitly explained
Selective reporting (re- High risk Comment: survival/failure rate was not consistent with the number of restora-
porting bias) tions considered as success or failure presented in table 1. We were unable to
use the data in the analysis
Other bias Low risk Comment: groups at baseline (age, gender, jaw, molar and operator) compara-
ble
Kemoli 2010
Administration setting: public primary schools
Country: Kenya
Informed decisions.
Kemoli 2010 (Continued)

Funding source: Netherlands Universities' Foundation for International Cooperation (NUFFIC), financial
support from the University of Nairobi, GC Europe and 3M ESPE (Netherlands)
Age: 6 to 8 years
Inclusion criteria:
• in good general health
• a proximal carious lesion in a primary molar having an occlusal access of approximately 0.5 mm to 1.0
mm in the bucco-lingual direction
Exclusion criteria: not stated
Restorative treatments received: proximal ART restorations in primary molars. Fuji IX (GC Europe) or
Ketac Molar Easymix or KME (3M ESPE AG); Ketac Molar Aplicap or KMA (3M ESPE AG)
Number of participants evaluated: 648 (number in each group not stated)
Withdrawals/loss to follow-up:
• overall 156 (19.4%)

• 3 (0.4%) cases that were improperly documented
• 38 (4.7%) could not be evaluated after placement because of truancy
• 115 (14.3%) withdrawals due to drop-outs, school-transferees, absentees and 1 death
Intervention: rubber dam: "The rubber dam (Medium-dark, Hygenic Dental Dam, HCM - Hygienic Cor-
poration, Malaysia) was used to isolate the tooth to be restored. A 2-minute gingival application of a
topical anaesthetic (Lidocaine 50mg/g cream) was used prior to the application of the rubber dam
clamp (FIT - Kofferdam Klammer, U67, Hager & Werken GmbH & Co. KG Germany). No other local anal-
gesic was used in the study"
Control: cotton rolls: "The cotton wool rolls were place buccally (maxillary teeth) or lingually and buc-
cally (mandibular teeth)"
Outcomes Outcomes: survival rate of restorations
Time points: within 2 hours of restoring each tooth, after 1 week, and 1, 5, 12, 18 and 24 months after
the restoration
Diagnostic criteria: restorations categorised as 0, 1 and 6 had survived; 2, 3, 7, 9 had failed; and 4, 5 and
8 were censored. 0 = present, good. 1 = present, marginal defects ≤ 0.5 mm in depth. 2 = present with
marginal defects > 0.5 mm deep. 3 = not present, restoration almost or completely disappeared. 4 =
not present, other restoration present. 5 = not present, tooth extracted/exfoliated. 6 = present, general
wear over the restoration of ≤ 0.5 mm at the deepest point. 7 = present, general wear over the restora-
tion of > 0.5 mm. 8 = undiagnosable. 9 = presence of secondary caries in relation to restoration
Sample size: calculated sample size was 382, but no details provided
Risk of bias

Informed decisions.
Kemoli 2010 (Continued)
Random sequence genera- Low risk Quote: "Using random numbers, the children were assigned to an isolation
tion (selection bias) method, material, operator and assistant. Each child had the restoration ran-
domly placed in the primary molar in either mandibular or maxillary arch"

(selection bias)
Blinding of participants High risk Comment: operators and participants could not be blinded
mance bias)
All outcomes
Blinding of outcome as- Low risk Quote: "The evaluators had not restored the cavities but had been trained and
sessment (detection bias) calibrated in the technique"
All outcomes
Comment: operators were not the assessors
Incomplete outcome data Unclear risk Quote: "Save for 3 cases that were improperly documented. Because of truan-
(attrition bias) cy 38 (4.7%) of the restorations the 801 documented cases could not be evalu-
All outcomes ated soon after placement, leaving only 763 restorations to be evaluated. Due
to the study-population attrition resulting from drop-outs, school-transferees,
absentees and one death, only 648 (80.9%) children could be evaluated at the
end of 2 years"
Comment: overall losses < 20%, and reasons were listed. However, no details
on the number and reasons of withdrawals in each group given
Selective reporting (re- Low risk Comment: outcomes were reported as planned
porting bias)
Other bias High risk Comment: groups at baseline (dental arch) not comparable
405 restorations were isolated with rubber dam, 101 of which were restora-
tions in the mandible; and 397 were isolated with cotton rolls, 141 of them
were restorations in the mandible (Fisher's Exact Test, P = 0.001)
Ma 2012
Recruitment period: 2009 to 2011
Administration setting: dental clinical of hospital
Country: China
Funding source: not stated
Age: not stated
Sex: not stated
Inclusion criteria (as translated):

Informed decisions.
Ma 2012 (Continued)
• with NCCLs in mandibular premolars
• in dentine but without pulp exposure
• lesions above the gingival margins
• teeth with NCCLs having no occlusal trauma
• teeth with NCCLs having vital pulps
Exclusion criteria: not stated
Restorative treatments received (as translated): composite restorations of NCCLs
Number of participants evaluated: 162; 162 teeth (rubber dam: 81; cotton rolls: 81)
Withdrawals/loss to follow-up: no losses to follow-up
Intervention: rubber dam (as translated): "isolated with rubber dam (Optra Dam, Ivoclar Vivadent, 0.22
˜ 0.27mm)"
Control: cotton rolls (as translated): "isolated with cotton rolls placed in buccal and lingual vestibule"
Outcomes Outcomes (as translated): failure rate
Time points: 6 months

after restorative treatment
Diagnostic criteria: failure criteria (as translated): restorations found not to exist was regarded as fail-
ure. No further detail was provided
Sample size calculation: no details reported
Risk of bias
Random sequence genera- Unclear risk Quote (as translated): "One hundred and sixty-two patients with non-carious
tion (selection bias) cervical lesions were stratified randomly distributed into two groups (n = 81)
from June 2009 to June 2011"
Comment: method of sequence generation not stated. Insufficient information

reported to make a judgement

(selection bias)
Blinding of participants High risk Comment: operators and participants could not be blinded
mance bias)
All outcomes
Blinding of outcome as- Unclear risk Not stated

sessment (detection bias)
All outcomes Comment: insufficient information reported to make a judgement
Incomplete outcome data Low risk Comment: no loss to follow-up

(attrition bias)

Informed decisions.
Ma 2012 (Continued)
All outcomes
Selective reporting (re- Low risk Comment: outcomes reported as planned

porting bias)
Other bias Unclear risk Comment: no data on group comparability
ART: atraumatic restorative treatment; NCCLs: non-carious cervical lesions; RCT: randomised controlled trial.
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Daudt 2013 Inappropriate statistical analysis (randomisation and analysis at tooth level without accounting for
the clustering effect of teeth within individual participants)
Fontes 2009 Inappropriate study design. The study authors kindly provided us with a prepublication copy of the
study and we were able to see that the study claimed to be performed using a split-mouth design,
but not carried out it in an appropriate way
Ganss 1999 Randomisation allocation not performed between the rubber dam and cotton rolls isolation
groups
Huth 2004 Study was a CCT as randomisation allocation was not performed between the 2 treatment groups,
and using teeth as the analysis unit
Raskin 2000 Inappropriate statistical analysis (randomisation and analysis at tooth level without accounting for
the clustering effect of teeth within individual participants)
Sabbagh 2011 Conference abstract without mentioning randomisation allocation between the 2 treatment
groups, and author contact failed
Smales 1993 Study was a CCT as randomisation allocation was not performed between the 2 treatment groups,
and using teeth as the analysis unit
Straffon 1985 Randomisation allocation not performed between the rubber dam and cotton roll isolation groups
and using tooth surfaces as the analysis unit
van Dijken 1987 Study was a CCT as randomisation allocation was not performed between the 2 treatment groups
CCT: controlled clinical trial.
Characteristics of studies awaiting assessment [ordered by study ID]
Alhareky 2014
Methods Design: split-mouth
Recruitment period: not reported
Administration setting: teaching clinic of dental school
Country: USA
Funding source: in part by US Department of Health and Human Services Health Resources and
Services Administration grant D84HP19955

Informed decisions.
Alhareky 2014 (Continued)
Participants Number of participants randomised: 42; 168 teeth (rubber dam: 84; Isolite system: 84)
Randomisation unit: teeth
Age: 7 to 16 years, mean age 12.3 years
Inclusion criteria:
• healthy children with no compromising medical or physical condition

• children with ≥ 1 caries-free permanent molar in each quadrant, with normal anatomy that qual-
ified for the application of pit and fissure sealants
• co-operative children
Exclusion criteria:
• history of chronic disease

• unable to return for follow-ups
• requiring < 4 pit and fissure sealants on permanent molars
• children with partially erupted molars
Restorative treatments received: pit and fissure sealing of permanent molar
Number of participants evaluated: 42; 168 teeth (rubber dam: 84; Isolite system: 84)
Withdrawals/loss to follow-up: no loss to follow-up
Intervention: RD: "First, gingival soft tissue surrounding the tooth was dried. Topical anesthesia
was achieved using 20 percent benzocaine gel, which was applied for one minute, according to
the manufacturer’s instructions. A wingless clamp appropriate for use on molars was selected and
then used in conjunction with a latex-free RD sheet. No bite block was used with the RD"
Control: IS: "First, the isthmus (narrow part in the middle of the IS plastic mouthpiece) was placed
at the corner of mouth, and the patient was instructed to open widely. The IS mouthpiece was then
inserted while folding the cheek shield forward toward the tongue retractor and sliding the isth-
mus into the cheek. The patient was asked to bite on the bite block part of the IS. Finally, the cheek
shield was tucked into the buccal vestibule, and the tongue retractor was tucked into the tongue
vestibule. The high-speed evacuation system was connected to the IS system, and a second high-
speed suction was used to evacuate the mouth during the sealant placement application"
Outcomes Treatment time, patient acceptance (evaluated using a questionnaire)
Notes Adverse events: not reported
Sample size calculation: not reported
Awaiting responses from authors on the details of the method of randomisation used, preforma-
tion of allocation concealment and funding sources
IS: Isolite system; RD: rubber dam.
DATA AND ANALYSES

Informed decisions.
Comparison 1. Rubber dam versus cotton rolls
Outcome or subgroup title No. of No. of Statistical method Effect size

studies partici-
pants
1 Survival rate (6 months) 1 162 Risk Ratio (M-H, Fixed, 95% CI) 1.19 [1.04, 1.37]
2 Survival rate (24 months) 1 559 Hazard Ratio (Fixed, 95% CI) 0.80 [0.66, 0.97]
Analysis 1.1. Comparison 1 Rubber dam versus cotton rolls, Outcome 1 Survival rate (6 months).
Study or subgroup Rubber dam Cotton roll Risk Ratio Weight Risk Ratio
n/N n/N M-H, Fixed, 95% CI M-H, Fixed, 95% CI
Ma 2012 74/81 62/81 100% 1.19[1.04,1.37]
Total (95% CI) 81 81 100% 1.19[1.04,1.37]

Total events: 74 (Rubber dam), 62 (Cotton roll)
Heterogeneity: Not applicable
Test for overall effect: Z=2.51(P=0.01)
Favours cotton roll 0.5 0.7 1 1.5 2 Favours rubber dam
Analysis 1.2. Comparison 1 Rubber dam versus cotton rolls, Outcome 2 Survival rate (24 months).
Study or subgroup Rubber Cotton roll log[Hazard Hazard Ratio Weight Hazard Ratio
dam Ratio]
N N (SE) IV, Fixed, 95% CI IV, Fixed, 95% CI
Kemoli 2010 303 256 -0.2 (0.1) 100% 0.8[0.66,0.97]
Total (95% CI) 100% 0.8[0.66,0.97]

Heterogeneity: Not applicable
Test for overall effect: Z=2.24(P=0.03)
Favours rubber dam 0.5 0.7 1 1.5 2 Favours cotton roll
ADDITIONAL TABLES
Table 1. Category of overall risk of bias

Risk of bias Interpretation Within a study Across studies
Low risk of bias Plausible bias unlikely to seriously Low risk of bias for all Most information is from studies at low risk of
alter the results key domains bias
Unclear risk of Plausible bias that raises some Unclear risk of bias for Most information is from studies at low or un-
bias doubt about the results ≥ 1 key domains clear risk of bias
High risk of bias Plausible bias that seriously weak- High risk of bias for ≥ 1 The proportion of information from studies at
ens confidence in the results key domains high risk of bias is sufficient to affect the inter-
pretation of results

Informed decisions.
Table 2. Effects of intervention: survival/loss rate

Study ID Restorative treat- Time points Result para- Results Comment
ment meters
Ma 2012 Composite restora- 6 months after the restora- Loss rate Lower failure rate in rubber Chinese
tions of NCCLs tion dam group reference,
translated
Carvalho Proximal ART restora- 6, 12, 18 and 24 months after Cumulative Both groups had similar sur- Excluded
2010 tions in primary molar the restoration survival rate vival rate from analy-
of restora- sis due to in-
tions consistent
data
Kemoli Proximal ART restora- Within 2 hours, 1 week, 1 Survival rate Significant higher 2-year -
2010 tions in primary mo- month, 5 months, 1 year, 1.5 of restora- survival rate was observed
lars and 2 years after the restorations in rubber dam group com-
tions pared to cotton roll isola-
tion group
ART: atraumatic restorative treatment; NCCLs: non-carious cervical lesions.
APPENDICES
Appendix 1. Cochrane Oral Health's Trials Register

("rubber dam*" or "oral dam*" or "dental dam*" or "latex dam*" or Kofferdam* or "Optra dam*" or "Optradam Plus" or Optidam* or
Flexidam* or "Hygenic Fiesta")
Appendix 2. Cochrane Central Register of Controlled Trials (CENTRAL) search strategy

#1 MeSH descriptor Dental restoration, permanent explode all trees
#2 MeSH descriptor Dental restoration, temporary explode all trees
#3 ( (dental in All Text near/5 restor* in All Text) or (teeth in All Text near/5 restor* in All Text) or (tooth in All Text near/5 restor* in All Text)
or (dental in All Text near/5 fill* in All Text) or (teeth in All Text near/5 fill* in All Text) or (tooth in All Text near/5 fill* in All Text) )
#4 MeSH descriptor Dental atraumatic restorative treatment this term only
#5 ( (dental in All Text or tooth in All Text or teeth in All Text) and ("atraumatic restorative treatment" in All Text or ART in All Text) )
#6 MeSH descriptor Dental amalgam this term only
#7 MeSH descriptor Glass ionomer cements this term only
#8 ( (dental in All Text or tooth in All Text or teeth in All Text) and (restor* in All Text and (inlay in All Text or in-lay in All Text or onlay in All
Text or on-lay in All Text or post* in All Text or dowel* in All Text or pin* in All Text) ) )
#9 ( (dental in All Text or tooth in All Text or teeth in All Text) and (amalgam* in All Text or resin* in All Text or cement* in All Text or ionomer*
in All Text or compomer* in All Text or composite* in All Text) )
#10 MeSH descriptor Crowns explode all trees
#11 ( (dental in All Text near/5 crown* in All Text) or (tooth in All Text near/5 crown* in All Text) or (teeth in All Text near/5 crown* in All Text) or
(dental in All Text near/5 coronal* in All Text) or (tooth in All Text near/5 coronal* in All Text) or (teeth in All Text near/5 coronal* in All Text) )
#12 MeSH descriptor Denture, partial explode all trees
#13 MeSH descriptor Dental veneers explode all trees

Informed decisions.
#14 ( (dental in All Text or tooth in All Text or teeth in All Text) and (bridge* in All Text or veneer* in All Text or pontic* in All Text or laminate*
in All Text) )
#15 (partial in All Text near/5 denture* in All Text)
#16 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15)
#17 MeSH descriptor Rubber dams this term only
#18 ( (rubber in All Text near/6 dam* in All Text) or (oral in All Text near/6 dam* in All Text) or (dental in All Text near/6 dam* in All Text) or
(latex in All Text near/6 dam* in All Text) or Kofferdam in All Text)
#19 ("Optra Dam" in All Text or "OptraDam Plus" in All Text or OptiDam in All Text or FlexiDam in All Text or "Hygenic Fiesta" in All Text)
#20 (#17 or #18 or #19)
#21 (#16 and #20)
Appendix 3. MEDLINE Ovid search strategy

1. exp Dental restoration, permanent/
2. exp Dental restoration, temporary/
3. ((dental or tooth or teeth) adj5 (restor$ or fill$)).ti,ab.
4. Dental atraumatic restorative treatment/
5. ((dental or tooth or teeth) and ("atraumatic restorative treatment" or ART)).ti,ab.
6. Dental amalgam/
7. Glass ionomer cements/
8. ((dental or tooth or teeth) and (restor$ and (inlay or in-lay or onlay or on-lay or post$ or dowel$ or pin$))).mp.
9. ((dental or tooth or teeth) adj5 (amalgam$ or resin$ or cement$ or ionomer$ or compomer$ or composite$)).mp.
10. exp Crowns/
11. ((dental or tooth or teeth) adj5 (crown$ or coronal$)).ti,ab.
12. exp Denture, Partial/
13. exp Dental veneers/
14. ((dental or tooth or teeth) adj5 (bridge$ or veneer$ or pontic$ or laminate$)).mp.
15. (partial adj5 denture$).mp.
16. or/1-15
17. Rubber dams/
18. ((rubber adj dam$) or (oral adj dam$) or (dental adj dam$) or (latex adj dam$) or Kofferdam).mp.
19. ("Optra Dam" or "OptraDam Plus" or OptiDam or FlexiDam or "Hygenic Fiesta").mp.
20. or/17-19
Appendix 4. Embase Ovid search strategy

1. exp Reparative dentistry/
2. ((dental or tooth or teeth) adj5 (restor$ or fill$)).ti,ab.
3. ((dental or tooth or teeth) and ("atraumatic restorative treatment" or ART)).ti,ab.
4. Dental alloy/

Informed decisions.
5. Glass ionomer/
6. ((dental or tooth or teeth) and (restor$ and (inlay or in-lay or onlay or on-lay or post$ or dowel$ or pin$))).mp.
7. ((dental or tooth or teeth) adj5 (amalgam$ or resin$ or cement$ or ionomer$ or compomer$ or composite$)).mp.
8. exp Crowns/
9. ((dental or tooth or teeth) adj5 (crown$ or coronal$)).ti,ab.
10. exp Denture
11. ((dental or tooth or teeth) adj5 (bridge$ or veneer$ or pontic$ or laminate$)).mp.
12. (partial adj5 denture$).mp.
13. or/1-12
14. ((rubber adj dam$) or (oral adj dam$) or (dental adj dam$) or (latex adj dam$) or Kofferdam).mp.
15. ("Optra Dam" or "OptraDam Plus" or OptiDam or FlexiDam or "Hygenic Fiesta").mp.
16. 14 or 15
17. 13 and 16
Appendix 5. LILACS BIREME Virtual Health Library search strategy

(dental or dentária or tooth or teeth or dente$ or diente$) [Words] and (Mh Rubber dams or "rubber dam$" or "dique$ de goma" or "dique$
de borracha" or "dental dam$" or "latex dam$" or "oral dam$" or Kofferdam or "Optra Dam" or "OptraDam Plus" or OptiDam or FlexiDam
or "Hygenic Fiesta") [Words]
Appendix 6. SciELO BIREME Virtual Health Library search strategy

rubber dam
Appendix 7. CBM search strategy

1. Mesh: rubber dam
2. Key word: rubber dam
3. #2 or #1
This search strategy was translated from Chinese.
Appendix 8. VIP search strategy

rubber dam
Appendix 9. CNKI search strategy

rubber dam
Appendix 10. US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the WHO International
Clinical Trials Registry Platform search strategy
rubber dam
Appendix 11. OpenGrey search strategy

rubber dam
Appendix 12. Sciencepaper search strategy

rubber dam
Informed decisions.
CONTRIBUTIONS OF AUTHORS
Screening the search results and retrieving the papers: Yan Wang (YW), He Yuan (HY).
Data extraction and risk of bias assessment: YW, HY and Chunjie Li (CL).
Analysing the data and interpreting the results: CL, YW and May CM Wong (MW).
Writing the results, discussion, conclusions and abstract: YW, CL, HY and MW.
Providing a clinical perspective: Xuedong Zhou (XZ), Jing Zou (JZ) and Zongdao Shi (ZS).
YW, CL, and HY contributed equally to producing this systematic review.
DECLARATIONS OF INTEREST
Yan Wang: none known.
Chunjie Li: none known.
He Yuan: none known.
May CM Wong: none known. May CM Wong is an editor with Cochrane Oral Health.
Jing Zou: none known.
Zongdao Shi: none known.
Xuedong Zhou: none known.
SOURCES OF SUPPORT
Internal sources
• West China School of Stomatology, Sichuan University, China.
• West China Hospital of Stomatology, Sichuan University, China.
• State Key Laboratory of Oral Diseases, Sichuan University, China.
External sources
• UK Cochrane Centre, UK.
• Cochrane Oral Health, UK.
• Cochrane Oral Health Global Alliance, Other.
The production of Cochrane Oral Health reviews has been supported financially by our Global Alliance since 2011 (ohg.cochrane.org/
partnerships-alliances). Contributors over the last year have been: British Association for the Study of Community Dentistry, UK; British
Society of Paediatric Dentistry, UK; Centre for Dental Education and Research at All India Institute of Medical Sciences, India; National
Center for Dental Hygiene Research & Practice, USA; New York University College of Dentistry, USA; NHS Education for Scotland, UK.
• National Institute for Health Research (NIHR), UK.
This project was supported by the NIHR, via Cochrane Infrastructure funding to Cochrane Oral Health. The views and opinions expressed
therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR, the NHS
or the Department of Health.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

Added participant acceptance/satisfaction as a secondary outcome.
Used risk ratio as a measure of the survival/success rate of the restorative treatment.
Specified types of subgroup analyses intended to perform.


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Cochrane

Rubber dam isolation for restorative treatment in dental patients

Wang Y, Li C, Yuan H, Wong MCM, Zou J, Shi Z, Zhou X

Wang Y, Li C, Yuan H, Wong MCM, Zou J, Shi Z, Zhou X.

Rubber dam isolation for restorative treatment in dental patients (Review)

Rubber dam isolation for restorative treatment in dental patients (Review) i

Rubber dam isolation for restorative treatment in dental patients

Editorial group: Cochrane Oral Health Group.

Data collection and analysis

PLAIN LANGUAGE SUMMARY

Quality of the evidence

Rubber dam isolation for restorative treatment in dental patients (Review) 2

Patient or population: dental patients

GRADE Working Group grades of evidence

Cochrane Database of Systematic Reviews

Types of participants • Cochrane Central Register of Controlled Trials (CENTRAL; 2016,

Rubber dam isolation for restorative treatment in dental patients (Review) 5

Data synthesis Results of the search

Rubber dam isolation for restorative treatment in dental patients (Review) 7

Figure 1. Study flow diagram.

Included studies Characteristics of the trial designs and settings

Rubber dam isolation for restorative treatment in dental patients (Review) 8

Rubber dam isolation for restorative treatment in dental patients (Review) 9

Rubber dam isolation for restorative treatment in dental patients (Review) 10

Rubber dam isolation for restorative treatment in dental patients (Review) 11

Rubber dam isolation for restorative treatment in dental patients (Review) 12

Rubber dam isolation for restorative treatment in dental patients (Review) 13

* Smales RJ. Rubber dam usage related to restoration quality

Rubber dam isolation for restorative treatment in dental patients (Review) 14

Additional references GRADEproGDT [Computer program]

Rubber dam isolation for restorative treatment in dental patients (Review) 15

Parmar 1998 Stewardson 2002

Reid 1991 Sutton 1996

* Indicates the major publication for the study

Characteristics of included studies [ordered by study ID]

Recruitment period: not stated

Administration setting: private dental clinic

Funding source: Dentsply DeTrey, Konstanz, Germany

Randomisation unit: participant

Age: 5.9 to 16.9 years, mean age 11.1 years

Sex: 23 boys, 49 girls

• participation in other studies evaluating parameters of stress

Rubber dam isolation for restorative treatment in dental patients (Review) 16

Ammann 2013 (Continued)

Restorative treatments received: fissure sealing in premolar/molar

Number of participants evaluated: 72 (rubber dam: 34; cotton rolls: 38)

Withdrawals/loss to follow-up: no withdrawals

Interventions Number of groups: 2

Outcomes Outcomes: treatment time

Notes Adverse events: not stated

No details on sample size or power calculation were provided

Bias Authors' judgement Support for judgement

Comment: method stated and appropriate

Allocation concealment Unclear risk Not stated

Blinding of outcome as- Unclear risk Not stated

Incomplete outcome data Low risk Comment: no withdrawals

Comment: insufficient information reported to use the data in the analysis

Rubber dam isolation for restorative treatment in dental patients (Review) 17

Recruitment period: not stated