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New Dual-cure Resin-based Material in Occlusal and Occluso-proximal Restorations of Primary Teeth: Results of a Randomized Clinical Trial

Abstract:

Background: The clinical performance of new restorative materials must be evaluated before recommending its use in primary teeth. Aim: This randomized clinical trial evaluated the survival rates of restorations in single and occluso-proximal cavities of primary teeth performed with a new dual-cure resin-based material in comparison with a resin-modified glass ionomer cement after 12 months of follow-up. Materials and methods: A total of 107 restorations were placed in 27 children by one experienced pediatric dentist. Two materials were tested: Vitremer and a dual-cure resin-based material with (CentionN+Adh) and without (Cention N–Adh) adhesive system application. Two calibrated and blinded examiners evaluated the restorations at 3, 6, and 12-month. The longevity of the restorations was analyzed using Kaplan-Meier survival curves and Log-rank test (α = 5%). Results: The overall survival rates after 12-month were 81.9% for Vitremer, 70.4% for Cention N+Adh, and 66.7% for Cention N–Adh, which had the poorer performance (HR = 0.54; 95% CI= 0.31–0.95; p = 0.031). When considering the type of the cavities, the difference was significant only for occluso-proximal cavities when Cention N–Adh was used (HR = 0.46; CI = 0.26–0.81; p = 0.008). Conclusion: All evaluated materials are suitable for restoring occlusal cavities after selective caries removal. However, Cention N needs to be used with adhesive in occluso-proximal cavities. Clinical significance: Cention-N can be used for deciduous teeth restorations, with similar longevity rates as resin modified glass ionomer cements. Trial registration number RBR-9nqszr.