Randomized 3-year Clinical Evaluation of Class I and II Posterior Resin Restorations Placed with a Bulk-fill Resin Composite and a One-step Self-etching Adhesive

Purpose: To evaluate the 3-year clinical durability of the flowable bulk-fill resin composite SDR in Class I and Class II restorations. Materials and Methods: Thirty-eight pairs of Class I and 62 pairs of Class II restorations were placed in 44 male and 42 female patients (mean age 52.4 years). Each patient received at least two extended Class I or Class II restorations that were as similar as possible. In all cavities, a one-step self-etching adhesive (XenoV+) was applied. One of the cavities of each pair was randomly assigned to receive the flowable bulk-fill resin composite SDR in increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface. The occlusal part was completed with an ormocer-based nanohybrid resin composite (Ceram X mono+). In the other cavity, only the resin composite CeramX mono+ was placed in 2 mm increments. The restorations were evaluated using slightly modified USPHS criteria at baseline and then annually for 3 years. Caries risk and bruxing habits of the participants were estimated. Results: No post-operative sensitivity was reported. At the 3-year follow-up, 196 restorations - 74 Class I and 122 Class II - were evaluated. Seven restorations failed (3.6%), 4 SDR-CeramX mono+ and 3 CeramX mono+ only restorations, all of which were Class II. The main reason for failure was tooth fracture, followed by resin composite fracture. The annual failure rate (AFR) for all restorations (Class I and II) was 1.2% for the bulkfilled restorations and 1.0% for the resin composite-only restorations (p > 0.05). For the Class II restorations, the AFR was 2.2% and 1.6%, respectively. Conclusion: The 4-mm bulk-fill technique showed good clinical effectiveness during the 3-year follow-up. Keywords: bulk fill, dental restorations, clinical, composite resin, nano, posterior, self-etching adhesive