A two-year randomized clinical trial of bulk-fill and ion-releasing composites with universal adhesives in class V carious lesions

一项为期两年的随机临床试验,研究了使用通用粘合剂对V类龋损进行大块填充和离子释放复合材料修复的效果。

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Abstract

OBJECTIVES: To evaluate the two-year clinical performance of Class V restorations in carious cervical lesions placed with bulk-fill resin composite or ion-releasing composite, combined with either fluoride-free or fluoride-releasing universal adhesives. MATERIALS AND METHODS: In this double-blind, randomized clinical trial, 140 Class V restorations were placed using four restorative systems: bulk-fill composite with fluoride-free adhesive, bulk-fill composite with fluoride-releasing adhesive, ion-releasing composite with fluoride-free adhesive, and ion-releasing composite with fluoride-releasing adhesive. Restorations were placed under rubber-dam isolation using selective enamel etching. Clinical evaluations were performed at baseline, 6 months, one year, and two years using periodontal indices and FDI criteria. Data were analyzed using Kruskal–Wallis, Friedman, Mann–Whitney U, and Wilcoxon signed-rank tests (α = 0.05). RESULTS: Recall rates were 96.4% at 6 months, 89.3% at 1 year, and 83.5% at 2 years. Periodontal parameters showed no significant differences among groups. No significant differences were observed between restorative systems for any FDI functional, biological, or esthetic criteria at any evaluation point. All restorations remained clinically acceptable, with no loss of retention, fractures, or secondary caries throughout the two-year follow-up. Marginal adaptation scores remained stable and comparable among all groups. CONCLUSIONS: All four restorative systems demonstrated comparable and favorable clinical performance over two years. The use of fluoride-releasing adhesives or ion-releasing composites did not confer additional clinical benefits under the conditions of this trial. CLINICAL RELEVANCE: Both the tested bulk-fill resin composite and ion-releasing composite deliver predictable short-term performance in Class V restorations, without additional benefit from fluoride-releasing components. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00784-026-06852-5.

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