Estupiñan‐Day 2006.

Methods	Design: cluster, parallel RCT Number of participants: 1629 children Setting: community setting Country: Ecuador, Panama and Uruguay Unit of randomisation: child Unit of analysis: tooth Follow‐up: 12, 24 and 36 months Dropout: 15.6% and 51.47% after 12 and 24 months, respectively
Participants	Number randomised (participants): 1629 children (868 ART group and 761 CT group)/ 6773 teeth (4976 ART and 1797 conventional) Number analysed: 3287 teeth Age mean and SD (range): 7‐9 years Gender: female 843 (51.38%), male 786 (48.62%) Average DMFT score: not reported Dentition: permanent Type of caries lesion: not reported Inclusion criteria Male and female school children, 7, 8, and 9 years of age in rural and urban schools Presence of ≥ 1 lesion with one of the following characteristics: 1) initial enamel caries, and 2) teeth with dentinal lesions on a first permanent molar Parental consent Exclusion criteria Lesions with very large or deep caries that are very close to the pulp Lesions where caries have compromised the pulp (inflammation or infection of the pulp) Healthy teeth without an apparent risk of caries as well as overall good health
Interventions	The study has 3 arms: ART performed by dentist + GIC ART performed by auxiliary + GIC CT + amalgam The ART procedure consisted of a manual excavation of dental caries and restoration with glass ionomer. CT with amalgam. No more details Use of anaesthesia was not reported in any group. The interventions were conducted by dentists and dental hygienists.
Outcomes	Failure rate (USPHS criteria) after 12 and 24 months. It was not reported which codes were considered success or failure. Pain, co‐operation (4 Likert scale questions) during the procedure Direct cost of the interventions
Notes	Funding: Inter‐American Development Bank Trial register number not reported Sample size calculated Results at 3 years not reported Interexaminer reproducibility > 0.75
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "In order to ensure balanced treatment groups within the schools, children were randomised in blocks of 4 or 10 depending on the size of the school. Schools with 15 children or fewer and, whenever possible, within a reasonable distance from one another were collapsed. The randomisation was accomplished using a computer‐based (SAS) block randomisation using random number seeds from a random digit table"
Allocation concealment (selection bias)	Low risk	Quote: "Assignment for all three countries was done in Washington, DC to ensure consistency"
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 PRAT project required its restoration evaluators to be trained and calibrated according to strict standard criteria so that their assessments were reliable and comparable" "At the end of the third year, an external international evaluator will conduct a final evaluation of the condition of restorations performed during the course of the project" Comment: not clear whether the assessments at 1 and 2 years were made by an operator who was not involved in the treatment phase
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: loss to follow‐up high at 2 years (51.47%)
Selective reporting (reporting bias)	High risk	Comment: results at 3 years not reported
Other bias	High risk	Comment: DMF scores not reported. Information about supply of water fluoridation between countries not provided. The analysis did not consider the intracluster correlation coefficient.