One-year clinical evaluation of class II bulk-fill restorations in primary molars: a randomized clinical trial

Abstract

This double-blind, randomized clinical trial aimed to compare the clinical performance and clinical time to restore occluso-proximal cavities in primary molars with bulk-fill resin and conventional resin. A total of 140 class II restorations in primary molars of 65 participants (mean age of 6.7 + 1.5) were placed in two random groups: bulk-fill and conventional resin. The restorations were evaluated using FDI criteria at the baseline, 6-month, and one year by a single calibrated examiner, and the clinical restorative time was measured with a digital timer. The success and survival of the restorations were evaluated with Kaplan-Meier graphs. The log-rank test compared the curves. Differences in restorative clinical time were compared using the Mann- Whitney U test. The level of significance was 5%. After one year, 115 restorations were evaluated. The success probability was 88.7% for Filtek Z350 XT and 85.9% for FiltekTM Bulk-fill, and for the survival probability, Filtek Z350 XT presented 90%, and FiltekTM Bulk-fill presented 93.7%. No significant difference was found between the success and survival curves (p=0.62), (p=0.51). The main reason for failure was marginal adaptation. Bulk- fill resin required 3O% less time than the conventional resin (p<0.001). Bulk- fill resin presented similar clinical performance to the conventional resin and required less restorative clinical time. It is an option to restore class II lesions of primary molars.