Abstract
The aim of this 3-year, randomized clinical trial (RCT) in split-mouth design was to explore the clinical survival of a Bis-GMA-free pit and fissure sealant (Helioseal F Plus) in comparison to a control material (Helioseal F). The initial population consisted of 92 adolescents. Follow-ups took place after one year (N = 85), two years (N = 82) and three years (N = 76) after application. At each examination, sealant retention and the presence of caries were recorded. The statistical analysis included the calculation of Kaplan–Meier survival curves, log-rank tests and a Cox proportional hazard regression model. No adverse events were documented. The proportion of completely intact sealants and those with minimal loss was almost identical in both groups, at 84.3% (Helioseal F; 113/134) and 81.7% (Helioseal F Plus; 107/131) after three years of observation. The regression analysis revealed an operator dependency, but no significant differences were found between the materials, the study centers, the chosen isolation technique, patient age or sex. After 3 years, 91.7% and 100.0% of all molars were free of non-cavitated carious lesions or carious cavities, respectively. It can be concluded that the new fissure sealing material can be considered as at least equivalent in terms of survival and retention behavior compared to the predecessor material.