A Randomized Controlled Clinical Trial Evaluating the Performance of Bis-GMA Free Resin Composite Posterior Restorations

Abstract

Objective: This study aims to assess the clinical performance of Bis-GMA free resin composites (RCs) in comparison with Bis-GMA based resin composites as posterior restorations during 1,3,6,9, and 12 months, using a split-mouth, double-blinded randomized design. Methods and Materials: The study included 20 participants who received a pair of class I or II bulk-fill composite restorations. One side of the mouth was filled with Bis-GMA free RC (Admira Fusion x-tra), while the other side received Bis-GMA based RC (X-tra fil). Restoration placement was done by a single operator following the manufacturer's guidelines and was finished and polished immediately following placement. Modified United States Public Health Services (USPHS) criteria have been adopted for restoration assessment at baseline (1 week), 1, 3, 6, 9, and 12 months. The statistical analysis was accomplished utilizing Wilcoxon tests, with a 0.05 significance level. Results: After 12 months, all patients attended the recall visits with a 100% recall rate. The Wilcoxon signed rank tests revealed insignificant differences between both groups (p?0.05) for all USPHS parameters. The two studied materials showed a decline from 100% clinically excellent scores, with a few recordings of clinically good scores at 12 months. However, most restorations maintained clinical Alpha and Bravo score throughout the 12-month period. Conclusions: The Bis-GMA-free RCs' clinical performance was comparable to that of Bis-GMA-based RCs in posterior permanent teeth restorations after 12 months. These findings suggest that Bis-GMA-free RCs can be considered a viable alternative to Bis-GMA-based RCs in clinical practice.