الفهرس 
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Abstract
This study was a split-mouth and double-blind longitudinal, prospective randomized clinical trial (RCT) To evaluate the clinical effectiveness of Bis-GMA free resin composites (RCs) compared to Bis-GMA based resin composites as posterior restorations, their performance was assessed at 1, 3, 6, 9, and 12 months.
The protocol of this study and the template informed consent form were reviewed with respect to scientific content and compliance with applicable research and human subjects’ regulations and approved by the IRBs/ECs [Institutional Review Boards/Ethical Committee] in the Faculty of Dentistry-Minia University with serial No. 419 on 27/06/2020 and also registered and approved on the Clinical Trials Registry (www. Clinicaltrials.gov) with trial number: NCT05480852 on 29/7/2022. Moreover, the study adheres to CONSORT guidelines.
Participants were asked to sign a printed informed consent explaining the aim of the study and allowed to contact the operator at moment by telephone. The data was reported to M.R. and Y.F.
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 clinical examiner and the volunteer were both blinded to the intervention. This study was conducted in the clinic of Operative Dentistry Department, Faculty of Dentistry, Minia University, Egypt, after the approval of the Ethics Committee in the Faculty of Dentistry – Minia University.The statistical analysis was accomplished utilizing Wilcoxon tests and Friedman’s test with a 0.05 significance level. After 12 months, all patients attended the recall visits with a 100% recall rate. The Wilcoxon signed rank tests and Friedman’s test revealed insignificant differences between both groups (p≤0.05) for all USPHS parameters.
The two materials that were examined exhibited a decrease in clinically excellent scores, with a small number of instances where clinically good scores were recorded after 12 months. However, the majority of restorations maintained their clinical Alpha and Bravo scores consistently over the course of 12 months. After 12 months, the clinical performance of Bis-GMA-free resin composites in posterior permanent teeth restorations was found to be similar to that of Bis-GMA-containing resin composites. These findings indicate that Bis-GMA-free resin composites may serve as a practical substitute for Bis-GMA-containing resin composites in clinical applications.
Limitations of the Study
• The study had a brief follow-up period, but additional visits for follow-up have been scheduled.
• Blinding of the operator was not feasible owing to the application of distinct restorative materials.
Clinical Recommendations
• It is strongly advised to extend the follow-up duration to validate the current findings of this study.
• Based on this study, it can be inferred that both BIS-GMA-free composites and BIS-GMA-containing composites exhibited satisfactory clinical performance throughout the one-year follow-up p.