Objectives: The aim of this randomized clinical trial (RCT) was to explore the clinical survival of a new, Bis-GMA-free pit and fissure sealant (Helioseal F Plus) in comparison to an established control material (Helioseal F).
Material and methods: This in vivo study was designed as a prospective, 2-year, two-centre RCT with a split-mouth design. The initial study population consisted of 92 adolescents who were followed up 1 month (N = 89), 6 months (N = 88), 1 year (N = 85) and 2 years (N = 82) after sealant application. The attrition rate was 10.9% after 2 years. At each examination, the sealant retention and 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.
Results: No adverse events during the application or any of the follow-up visits were documented. The proportion of completely intact sealants and those with minimal loss was almost identical in both groups at 85.9% (Helioseal F Plus) and 86.5% Helioseal F) after 2 years of observation. The regression analysis revealed operator dependency; no significant differences were found between the materials, the study centres, the chosen isolation technique and patient age or sex.
Conclusion: The newly developed sealant can be evaluated as at least equivalent in terms of survival and retention behaviour compared to the established control material.
Clinical relevance: The new sealant can be recommended for clinical use. With respect to the material properties (Bis-GMA-free, less light polymerisation time and better thixotropic behaviour), it offers additional advantages with clinical relevance.
Keywords: Caries prevention; Kaplan–Meier statistics; Pit and fissure sealant; RCT; Retention rate; Split-mouth design; Survival probability.
© 2022. The Author(s).