Roeleveld 2006.

Methods	Design: parallel RCT Number of participants: 217 Setting: not reported Country: Tanzania Unit of randomisation: child Unit of analysis: child Follow‐up: 7 and 12 months Dropout: 10.1% and 11.1% after 7 and 12 months, respectively
Participants	Number randomised (participants): 217 participants in 3 arms (77 ART group, 72 CT group and 68 CarisolvTM group) Number analysed: 109 children (57 ART and 52 conventional) Age mean and SD (range): 7.5 years SD = 0.57 (6‐7 years) Gender: female 123 (56,68%), male 94 (43.32%) Average DMFT score: not reported Dentition: primary Type of caries lesion: multiple‐surface caries lesion Inclusion criteria: ≥ 1 class II cavity in a primary molar, accessible to hand instruments, with an untreated tooth adjacent to cavity, and no pulp exposure Exclusion criteria: not reported
Interventions	Three treatment arms: Group 1: ART approach + H‐GIC Group 2: CT + H‐GIC Group 3: chemo‐mechanical technique with CarisolvTM + H‐GIC With the ART approach, only hatchets and excavators were used. The CT group was treated by excavation with a stainless steel bur without water cooling (speed: ± 750 rpm). For CarisolvTM group, excavation was performed with special hand instruments after the application of the gel. In all groups a matrix band and wooden wedges were inserted after cleaning the cavity. Cotton wool rolls were used to isolate the cavity so as to prevent contamination with saliva and/or blood. The smear layer was removed from the dentine by conditioning for 15 seconds and rinsed and dried with respectively 3 wet and 3 dry cotton pellets. Hand‐mix GIC (Fuji IX) was placed into the cavity, using the finger press method; Vaseline was applied to the index finger and pressed on for 3 seconds, the finger being removed sideways. No local anaesthesia was used in any group. Interventions were conducted by 4 dentists.
Outcomes	Success rate was evaluated through ART criteria. Codes 00 or 10 = success; codes 11, 12, 13, 20, 21, 30 or 40 = failure Residual caries and cervical was assessed on bite wing radiographs after the completion of the restorative procedure according to the following scale: 1 = definitely present (failure), 2 = probably present (failure) , 3 = not present (success)
Notes	Funding: GC Europe provided the GIC; Medi Team provided Carisolv and blunt instruments Trial register number not reported Sample size not calculated Interexaminer reproducibility ranged between 0.66 and 0.84
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “217 children were randomly divided into three groups for treatment with one of three different methods” Comments: insufficient information about the sequence generation process
Allocation concealment (selection bias)	Unclear risk	Comments: not reported
Blinding of participants and personnel (performance bias) ‐ participant	High risk	Comments: no information provided, but the participants could tell whether manual or rotary instruments were used
Blinding of participants and personnel (performance bias) ‐ operator All outcomes	High risk	Comments: blinding not possible ‐ operator knew the intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: “The restorations were evaluated after 7 months (first evaluation) and one year (second evaluation) by 4 final‐year students from The Netherlands” Comments: unclear if different from who was involved in placing them. Blinding would have been possible given that all restorations were GIC.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "There were 193 children present at the second evaluation (t=2), 149 of them could participate in the scoring for success or failure of the restorations." Comments: loss to follow‐up was low at 1 year (12%). Reasons for missing outcomes were not reported.
Selective reporting (reporting bias)	Low risk	All prespecified outcomes reported
Other bias	Unclear risk	Comments: baseline characteristics and details about co‐interventions not reported