Kemoli 2010.

Study characteristics
Methods	Design: parallel‐group RCT Recruitment period: not stated Administration setting: public primary schools Country: Kenya Funding source: Netherlands Universities' Foundation for International Cooperation (NUFFIC), financial support from the University of Nairobi, GC Europe and 3M ESPE (Netherlands)
Participants	Number of participants randomised: 804; 804 teeth (rubber dam: 404; cotton rolls: 397) Randomisation unit: participant/tooth Age: 6 to 8 years Sex: 454 boys, 350 girls Inclusion criteria: aged 6 to 8 years 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 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 dropouts, school‐transferees, absentees and 1 death
Interventions	Number of groups: 2 Intervention: rubber dam: "The rubber dam (Medium‐dark, Hygenic Dental Dam, HCM ‐ Hygienic Corporation, Malaysia) was used to isolate the tooth to be restored. A 2‐minute gingival application of a topical anaesthetic (Lidocaine 50 mg/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 analgesic was used in the study" Control: cotton rolls: "The cotton wool rolls were place buccally (maxillary teeth) or lingually and buccally (mandibular teeth)" Restorative treatment: proximal ART in primary molars
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 restoration of > 0.5 mm. 8 = undiagnosable. 9 = presence of secondary caries in relation to restoration
Notes	Adverse events: not reported Sample size: calculated sample size was 382, but no details provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Using random numbers, the children were assigned to an isolation method, material, operator and assistant. Each child had the restoration randomly placed in the primary molar in either mandibular or maxillary arch" Comment: method stated and appropriate
Allocation concealment (selection bias)	Unclear risk	Not stated Comment: insufficient information reported to make a judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: operators and participants could not be blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The evaluators had not restored the cavities but had been trained and calibrated in the technique" Comment: operators were not the assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "Save for 3 cases that were improperly documented. Because of truancy 38 (4.7%) of the restorations the 801 documented cases could not be evaluated soon after placement, leaving only 763 restorations to be evaluated. Due to the study‐population attrition resulting from dropouts, school‐transferees, absentees and 1 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 for withdrawals in each group given
Selective reporting (reporting bias)	Low risk	Comment: outcomes were reported as planned
Other bias	High risk	Comment: groups at baseline (dental arch) not comparable 405 restorations were isolated with rubber dam, 101 of which were restorations 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)