Clinical performance of BioCoat™ and Fissurit FX: a randomized 18-month split-mouth study

Pit and fissure sealants (PFS) are effective in preventing occlusal caries. This randomized split-mouth clinical study aimed to compare the 18-month clinical performance of the bioactive resin-based PFS (BioCoat™) with a fluoride-containing conventional resin-based PFS (Fissurit FX) and to assess the influence of patient-related factors on material success. Sixty-three pediatric patients (aged 7-9) requiring non-invasive PFS were included. BioCoat™ (Group 1) and Fissurit FX (Group 2) were applied to contralateral mandibular permanent first molars. Clinical evaluations were performed at 3rd, 6th, 9th, 12th, and 18th months using modified USPHS criteria. Kaplan-Meier survival analysis and logistic regression were applied. At 18 months, success rates were 90.2% for BioCoat™ and 88.2% for Fissurit FX, with no statistically significant difference between groups (p > 0.05). Both materials showed similar performance in marginal discoloration-adaptation, retention and secondary caries (p > 0.05). Median survival times were 17.72 months (BioCoat™) and 17.49 months (Fissurit FX), showing no significant difference (p = 0.744). No significant effect of patient-related factors on material success was determined (p > 0.05). BioCoat™ demonstrated comparable long-term clinical performance to Fissurit FX. Its bioactive properties may provide additional preventive benefits, supporting its safe use in pediatric dentistry.