Two-year randomized clinical trial to evaluate the performance of posterior bulk-fill resin composite with ionic releasing restorative material
Ahmad Gamal Mohamed Raghip, John C. Comisi, Hamdi H. Hamama, Salah Hasab Mahmoud
Abstract
OBJECTIVES: To compare the two-year clinical performance of a bioactive ionic resin restorative (Activa™ BioActive-Restorative™) with that of a conventional bulk-fill composite (Filtek™ One Bulk Fill Restorative) in Class I posterior restorations. METHODS: A randomized, double-blind, split-mouth clinical trial was conducted involving 22 patients (aged 25-55 years) who required the restoration of bilateral posterior teeth with ICDAS score five lesions. A total of 44 restorations were placed: 22 used Activa™ BioActive-Restorative™ (BIR) and 22 used Filtek™ One Bulk Fill Restorative (BFC). Cavity preparation included selective caries removal and selective enamel etching, followed by the application of adhesive. Clinical evaluations using modified FDI criteria were conducted at 3, 6, 12, and 24 months. Statistical analyses employed Chi-square, Fisher's exact test, and Cochran's tests. RESULTS: Both materials demonstrated excellent performance across all clinical parameters, with no failures or secondary caries reported over a 24-month period. No statistically significant differences were observed between groups at the 3-, 6-, or 12-month follow-ups. However, significant differences were identified at 24 months in surface luster, occlusal wear, anatomical form, and material fracture (p < 0.05), favoring the BIR group. Intra-group analysis also revealed significant changes over time in both groups. CONCLUSIONS: When combined with an adhesive protocol, BIR exhibited performance similar to a traditional bulk-fill composite over two years, showing improved long-term stability in specific parameters. Its bioactive characteristics and excellent wear resistance position it as a strong alternative for posterior restorations. CLINICAL SIGNIFICANCE: Bioactive restorative materials may enhance the long-term performance of posterior tooth restorations when used in conjunction with appropriate bonding techniques.