Supplementary Material for: Do fluoride-releasing restorative materials prevent the development of caries around restorations in deciduous and permanent teeth? A systematic review and meta-analysis

Introduction: The main cause of failure in restorations is the development of caries around restorations (CAR). Therefore, the aim of this study was to assess the evidence related to the development of CAR with fluoride-releasing restorative materials compared to non-fluoride releasing in deciduous and permanent teeth. Methods: Randomized clinical trials were included. Literature searches were conducted without language/data restrictions in 6 databases and in the grey literature in June 2024. ROB2 tool assessed the risk of bias. Through meta-analyses, expressed by the risk difference (RD) with a 95% confidence interval, the outcome was evaluated considering the follow-up period (12, 18-24 and ≥36 months), type of dentition and fluoride-releasing restorative materials, number of surfaces treated, and the type of dental isolation performed. Meta-regression models were applied with the above variables as moderators. The certainty of the evidence was assessed by GRADE. Results: Forty-six studies were selected. Among them, 29 presented some concerns and 9 showed high risk of bias. The type of dentition and dental materials, number of surfaces, and dental isolation did not influence the outcome (p>0.05). Although after 36 months of follow-up, deciduous and permanent teeth restored with fluoride-releasing materials had a lower risk of CAR (RD -0.015 [-0.024, -0.006] p=0.002 I2=0%), the moderators did not influence this effect by meta-regression models. The certainty of the evidence ranged from low to moderate. Conclusion: Fluoride-releasing restorative materials were more effective in preventing CAR after 36 months of follow-up. However, this result should be interpreted with caution, considering the low to moderate certainty of the evidence, the included studies’ risk of bias, and the small risk difference.