Randomized controlled clinical trial of a highly filled flowable composite in non-carious cervical lesions: 3-year results.

ABSTRACT

OBJECTIVES: This prospective, randomized, split-mouth clinical trial assessed the 3-year clinical performance of a highly filled flowable composite and a conventional paste-type composite in non-carious cervical lesions (NCCLs). MATERIALS AND METHODS: A total of 84 NCCLs in 27 subjects were included in this split-mouth design study and randomly divided into two groups a highly filled flowable composite Clearfil Majesty ES Flow group (ES, n = 42) and a conventional paste-type composite Majesty group (MJ, n = 42). Clearfil SE Bond was used following the manufacturer's instructions. The restorations were evaluated at baseline (BL) and 1, 2, and 3 years using FDI (World Dental Federation) criteria. Data were analysed by a paired chi-squared test for intergroup comparisons and the Friedman test for intragroup comparisons (α = 0.05). RESULTS: Both groups had a 97.3% retention rate at the 3-year evaluation. The acceptable scores (FDI scores 1-3) for each criterion exhibited no significant difference between the MJ and ES groups at any time point (p = 1.00). The marginal adaptation performance of ES was significantly better than that of MJ at every evaluation point (p < 0.05). CONCLUSIONS: The 3-year clinical performance of ES in NCCLs was similar to that of MJ. When the restorations were clinically acceptable, ES showed better marginal adaptation than MJ. CLINICAL RELEVANCE Compared with conventional paste-type composites, highly filled flowable composites showed similar clinical performance and better marginal adaptation for restoring NCCLs after 3 years. TRIAL REGISTRATION TRN ChiCTR1900028484 . Date of registration December 22, 2019, retrospectively registered.