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

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 HOW TO CITE THIS ARTICLE: da Cunha CM, Wambier LM, Paris Matos TD, et al. New Dual-cure Resin-based Material in Occlusal and Occluso-proximal Restorations of Primary Teeth: Results of a Randomized Clinical Trial. Int J Clin Pediatr Dent 2022;15(1):38-46.