Florio 2001.
| Methods | Trial design: parallel‐group study design, where individuals were randomly assigned to 3 treatment arms Follow‐up: 12 months Study was started in 1998 | |
| Participants | Location: 4 public day nursery schools (families at low economic level), Brazil Inclusion criteria: children with first permanent molars with restricted enamel decay on occlusal surfaces Age at baseline: 6 years Baseline caries: sealant group: mean dmfs 3.8 (SD 2.5); fluoride varnish group: 4.5 (SD 2.7) Number randomly assigned: 34 (sealant group 12, varnish group 11, control group 11 (with total 108 teeth; mean number of teeth 3.2 per child) Number evaluated: 31 (10 in sealant group; 11 in fluoride varnish group; 10 in control group) | |
| Interventions | Comparison: resin‐modified glass ionomer fissure sealant vs fluoride varnish
3 treatment arms
Group 1: sealant group (resin‐modified glass ionomer Vitremer), applied on occlusal surfaces of first permanent molars with restricted enamel decay. No resealing
Group 2: fluoride varnish group (Duraphat, sodium fluoride (NaF)), applied every 6 months on occlusal surfaces of first permanent molars with restricted enamel decay
Group 3: control group (only sealant and fluoride varnish groups were used in this review) Co‐interventions: fluoridated tap water. Children received professional prophylaxis during dental examination visits |
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| Outcomes | Arrestment of enamel caries lesion or progression into dentine was noted at 12 months of follow‐up To evaluate the caries progression rate, digital radiograph + endoscopic exam was used. Examinations were carried out by the same dentist who administered the interventions | |
| Notes | 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 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 children (17%) in sealant group and 0/11 children (0%) in varnish group No description was given of reasons for drop‐outs 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: Pre‐specified caries outcome (in methods) was reported in the pre‐specified way |
| Other bias | High risk |
Comparability of groups: Baseline mean dmfs was 3.8 (SD 2.5) in sealant group and 4.5 (SD 2.7) in fluoride varnish group Comment: imbalanced groups Co‐interventions: Co‐interventions in sealant and fluoride varnish groups: water supply fluoridation; 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 |