Abstract
BACKGROUND: Cervical carious lesions present a clinical challenge due to several factors and require restorative materials with optimal performance. This trial evaluated the clinical performance and cost-effectiveness of low-shrinkage giomer resin composite (LS-GRC) compared to resin-modified glass ionomer (RMGI) for restoring cervical carious lesions over a 12-month period. PARTICIPANTS AND METHODS: A total of 56 class V cavities were randomly assigned to two groups (n = 28). Intervention group received LS-GRC (Beautifil II LS, Shofu Dental Corporation, Kyoto, Japan), and control group received RMGI (Fuji II LC, GC Corporation, Tokyo, Japan). Restorations were evaluated using revised FDI criteria at baseline, 6, and 12 months. Data were statistically analyzed with a significance level of P ≤ 0.05. Intergroup comparisons were assessed with Chi-squared test, while intragroup comparisons were assessed with Cochran's Q test. Incremental cost-effectiveness ratio (ICER) and cost per success ratio (CPSR) were used for cost-effectiveness analysis. RESULTS: After 12 months, intergroup comparisons revealed no significant differences for all outcomes (P > 0.05), except for surface luster and texture, which favored LS-GRC (P < 0.05). Intragroup comparisons revealed no significant differences within LS-GRC group (P > 0.016), while within RMGI group, significant differences were observed for surface luster and texture after 12 months (P < 0.016). ICER analysis showed that the cost for each additional 1% improvement in clinical outcomes with LS-GRC was approximately 1.6 times higher than that of RMGI. The CPSR for LS-GRC was 4.6% lower than that of RMGI, indicating that, despite its higher initial cost, LS-GRC provided comparable clinical performance, with significantly improved esthetic surface quality and favorable cost-effectiveness over the 12-month period. CONCLUSIONS: LS-GRC and RMGI exhibited comparable performance and were clinically acceptable after 12 months. CLINICAL RELEVANCE: Low-shrinkage giomer resin composite offers bioactivity, superior restoration integrity, and excellent esthetics, helping achieve optimal cervical restorations with improved clinical success, durability, and sustained cost-effectiveness. TRIAL REGISTRATION: https://clinicaltrials.gov/ , (NCT05930548), 30-06-2023.