Twelve-month Clinical Effectiveness of Prevocare Sealant in Field Conditions

Objective: This randomized controlled clinical trial aimed to assess the effectiveness of a clear local–made sealant by comparing its retention and caries prevention with a standard imported sealant under field conditions at 12 months. Methods: The sample included 138 pairs of contralateral lower first permanent molars of children from grade 1-3 (aged 6-9 years old) who met the eligible criteria. Prevocare (Faculty of Dentistry, Chulalongkorn University) and Delton (Dentsply International, USA) were randomly placed on each molar by one dentist using a mobile dental unit and equipments at the schools. The sealed teeth were examined for their retention and caries formation after 6 and 12 months by a different examiner. Sealant retention was assessed as “success” if the sealant was still present on all pits and fissures and “failure” if partial loss or complete loss occurred. Using a confidence interval approach, the two groups were considered equivalent if the difference in retention rates was not more than 10%. Results: 127 pairs of teeth (92%) remained at the end of the study. The mean age of the students was 7.83 ± 0.84 years. The mean retention rates at 6 months of Delton and Prevocare were 96.9% (95% CI: 93.9, 99.9) and 98.5% (95% CI: 96.3, 100%), respectively. The mean difference in retention rates between the two groups was 1.5 (95% CI: -2.9, 6). At 12 months, the mean retention rates of Delton and Prevocare were 93.7% (95% CI: 89.4, 98%) and 94.5% (95% CI: 90.5, 98.5%) with the mean difference between both groups of 0.8% (95% CI: -5.9, 7.6). No carious lesions developed during this trial. Conclusion: The clinical performance of Prevocare, a locally-made sealant, is as good as Delton, when evaluated after 12 months. This study was supported by Faculty of Dentistry Research Fund, Chulalongkorn University.