Design: Multi-centre split mouth randomised controlled trial. Intervention Following prophylaxis, isolation, etching and drying the allocated resin-based fissure sealant (RBS) was applied according to the manufacturer’s instructions. Reviews were undertaken by a blinded observer at 6,12,18 and 24 months. Operators and observers were calibrated for ICDAS .
Outcome measure: The primary outcome was the presence of an ICDAS (International Caries Detection and Assessment System) 3-6 lesion on sealed tooth during the two-year follow-up. Sealant retention was a secondary outcome.
Results: Four hundred children (663 tooth pairs) were randomised, 290 children (483 tooth pairs) completed the two-year follow up. There was a lower risk of ICDAS 3-6 lesions in sealed molars; Hazard ratio [HR] = 0.16 (95% CI: 0.14 – 0.19). The effect was similar for both fluoride; HR= 0.15 (95% CI: 0.12 – 0.19) and non-fluoride sealants; HR= 0.18 (95% (CI: 0.15 – 0.21)
Conclusions: Sealant placement reduced the risk of ICDAS 3-6 lesions at 24 months; similar reductions in caries were seen for fluoride and non-fluoride sealants.