Fissure sealant therapy as a portable community-based care in deprived regions: Effectiveness of a clinical trial after 1 year follow-up

The aim of this study was to evaluate the effectiveness of the fissure sealant therapy in suboptimal setting (as part of a community-based program using the portable equipment and provided by dental students) on the caries status of school children. This pragmatic split-mouth randomised clinical trial was conducted in rural area of Iran. At baseline, 124 patients, including 185 paired teeth with deep pits and fissures of opposite quadrants that were either healthy or at early stages of enamel decay (International Caries Detection and Assessment System [ICDAS] 0-2), were randomly allocated to receive fissure sealant or acted as control. The incidence of new caries (ICDAS code 3-6) and the sealant's retention status after 1-year follow-up were evaluated. Using chi-square test, the relative risk (RR) and the Number Needed to Treat (NNT) to prevent new caries were calculated. After 1 year, 109 patients including 163 paired teeth were available. Sixty-seven (41.4%) and 44 (27.2%) teeth had complete and partial retained sealants respectively. The risk of caries incidence in non-sealed teeth was almost three times more than sealed teeth (RR = 2.88, 95% CI: 1.4-1.97,p = 0.002) and the NNT was 10 (95% CI: 6-26). A significant association was noted between the status of sealant retention after 1 year and the incidence of new caries (p < 0.001). Fissure sealant as part of a community-based program was effective in controlling caries incidence.