Comparative evaluation of bioactive alkasite-based material in different application modes: a 1-year randomized controlled clinical trial

Abstract

This study evaluated the one-year clinical performance of Cention N, a new alkasite bioactive restorative material, compared to a conventional bulk-fill composite resin in 12 patients aged 18–45 years with class I cavities. The patients were randomly assigned to three groups: Group I (Cention N without adhesive), Group II (Cention N with adhesive), and Group III (Filtek Bulk Fill composite resin). The restorations were monitored at baseline, three, six, and twelve months using the FDI criteria, assessing marginal staining, recurrent caries, and postoperative sensitivity. Statistical analysis was performed using the Monte Carlo correction, chi-square test, and Friedman’s test (p ≤ 0.05). The results showed clinically acceptable FDI scores for all restorations at each time interval with no significant differences between the groups (p ≥ 0.05). However, Cention N without adhesive demonstrated slightly inferior outcomes in postoperative sensitivity and marginal staining at the six- and twelve-month intervals. Overall, both materials performed similarly in terms of clinical performance within the first year, though Cention N without adhesive showed marginally lower, but still acceptable, results. Trial registration: ClinicalTrials.gov NCT06273410: 13/10/2022.