Florio 2001.

Study characteristics
Methods	Trial design: parallel group, where individuals were randomly assigned to 3 treatment arms Follow‐up: 12 months Started: 1998
Participants	Location: 4 public day nursery schools (families at low economic level), Brazil Inclusion criteria: children with FPMs with restricted enamel decay on occlusal surfaces Age at baseline: 6 years Sex: not reported Baseline caries: FS group: mean dmfs 3.8 (SD 2.5); FV group: 4.5 (SD 2.7) Number randomly assigned: 34 (FS group 12, FV group 11, control group 11 (with total 108 teeth; mean number of teeth 3.2 per child) Number evaluated: 31 (10 in FS group; 11 in FV group; 10 in control group)
Interventions	Comparison: resin‐modified glass ionomer FS vs FV 3 treatment arms Group 1: FS group (resin‐modified glass ionomer Vitremer), applied on occlusal surfaces of FPMs with restricted enamel decay. No resealing Group 2: FV group (Duraphat, sodium fluoride), applied every 6 months on occlusal surfaces of FPMs with restricted enamel decay Group 3: control group (Only FS (group 1) and FV (group 2) were used in this review) Co‐interventions: fluorinated tap water. Children received professional prophylaxis during dental examination visits
Outcomes	Primary outcome Arrestment of enamel caries lesion or progression into dentine was noted at 12 months of follow‐up. To evaluate the caries progression rate, used digital radiograph + endoscopic examination. Examinations were carried out by the same dentist who administered the interventions
Notes	Inter‐rater agreement: not applicable Sealant retention: complete sealant retention was 66% at 12 months Funding source: FAPESP/Brazil (São Paulo Research Foundation is an independent public foundation)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Table of random numbers was used. Comment: information was obtained from study authors.
Allocation concealment (selection bias)	Unclear risk	No information was provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding not possible as sealants can be seen.
Blinding of outcome assessor (detection bias)	High risk	No blinding of outcome assessor was performed. Comment: additional information was obtained from study authors.
Incomplete outcome data (attrition bias) All outcomes	High risk	Missing data: 2/12 (17%) children in FS group and 0/11 (0%) children in FV group Reasons for dropouts no given. Comment: imbalanced groups
Selective reporting (reporting bias)	Low risk	Outcome reported: arrestment of enamel caries lesion or progression into dentine at 12 months of follow‐up. Comment: prespecified caries outcome (in methods) was reported in the prespecified way.
Other bias	High risk	Comparability of groups: baseline mean dmfs was 3.8 (SD 2.5) in FS group and 4.5 (SD 2.7) in FV group Comment: imbalanced groups. Co‐interventions: co‐interventions in FS and FV groups: water supply fluorination; professional prophylaxis during follow‐up consultations; children individually informed about concepts of oral health. Additional information was obtained from study authors. Comment: similar co‐interventions in both groups.