24-month efficacy of bioactive versus fluoride sealant for non-cavitated occlusal caries in adults: a randomized clinical trial

Abstract

Abstract There is a recent suggestion by the American Academy of Pediatric Dentistry to seal initial non-cavitated carious lesions in adults. The aim of the present study was to evaluate the sealant retention and inhibition of initial carious lesion progression of the bioactive fissure sealant with SmartCap technology “Biocoat” compared to fluoride releasing fissure sealant “Clinpro sealant” over 24 months in non-cavitated occlusal carious lesions in adults. The present study is a randomized clinical trial, following a parallel group design with superiority framework and 1:1 allocation ratio. Thirty-six participants with 64 non-cavitated occlusal carious lesions were divided into two groups according to random allocation sequence (n = 32); either Biocoat (intervention) or Clinpro (control). Sealants were assessed at baseline, 12 and 24 months for retention and caries progression. Statistical analysis was performed by MedCalc 22 software for Windows. Intergroup comparison between sealants within each follow-up period was done using the Chi-Square test ( p  ≤ 0.05). Intragroup comparison within each intervention to assess change in clinical performance through time was performed by the Cochran’s Q test ( p  ≤ 0.016). After 24 months, two sealants in Biocoat group and 11 sealants in Clinpro group failed due to loss of retention or caries progression. Biocoat has shown 93.75% success rate, while Clinpro has shown 65.62% success rate after 24 months. The relative risk (RR) was 0.18 (95% CI 0.04374 to 0.7558), showing 82% less risk of failure of Biocoat when compared to Clinpro sealant, and this was statistically significant ( p  = 0.0190). Biocoat sealant showed better retention rate and inhibition of initial carious lesion progression after 24 months when compared to fluoride releasing sealant in non-cavitated occlusal caries in adults. Clinical relevance : The present study supports the suggestion of AAPD on sealing initial carious lesions. Sealing of initial non-cavitated occlusal carious lesions is a conservative and successful approach and should be implemented in routine dental practice in adults with recent history of dental caries. Trial registration : The present clinical trial was retrospectively registered on clinicaltrials.gov on 22-05-2023 (NCT05891288).