Clinical performance of an alkasite-based bioactive restorative in class II cavities: a randomized clinical trial

Abstract Objective This clinical study aimed to evaluate the clinical performance of an alkasite-based bioactive material by comparing it with a resin composite (RC) in the restoration of Class II cavities over a year. Methodology A hundred Class II cavities were restored at 31 participants. Groups were as follows: Cention N (CN) (Ivoclar Vivadent, Schaan, Liechtenstein) and G-ænial Posterior (GP) (GC, Tokyo, Japan) in combination with G-Premio Bond (etch&rinse). Restorative systems were applied following manufacturers’ instructions. They were finished and polished immediately after placement and scored based on retention, marginal discoloration, marginal adaptation, sensitivity, surface texture, and color match using modified USPHS criteria after 1 week (baseline), 6 months, and 12 months. Statistical analyses were performed using chi-square, McNemar’s, and Kaplan Meier tests. Results After 12 months, the recall rate was 87%. Survival rates of CN and GP restorations were 92.5% and 97.7%, respectively. Three CN and one GP restorations lost retention. Seven CN (17.9%) and five (11.6%) GP restorations were scored as bravo for marginal adaptation and no significant difference was seen between groups (p=0.363). One (2.7%) CN and two GP (4.7%) restorations were scored as bravo for marginal discoloration, but no significant difference was observed between groups(p=1.00). For surface texture, three (8.1%) CN and three (7%) GP restorations were scored as bravo (p=1.00). None of the restorations demonstrated post-operative sensitivity or secondary caries at any examinations. Conclusion The tested restorative materials performed similar successful clinical performances after 12 months. ClinicalTrials.gov (NTC04825379).

摘要 研究目的
本临床研究旨在评估一款碱土基生物活性材料的临床性能，为期12个月，将其与树脂复合材料（resin composite, RC）用于恒牙Ⅱ类洞修复的效果进行对比。

研究方法
本研究对31名受试者的100个恒牙Ⅱ类洞实施了修复治疗。试验分组如下：Cention N（CN，义获嘉伟瓦登特公司，列支敦士登沙恩），以及搭配酸蚀冲洗型粘接剂G-Premio Bond的G-ænial Posterior（GP，GC公司，日本东京）。修复操作严格遵循厂商说明书进行，修复体就位后即刻完成打磨抛光。分别在术后1周（基线）、6个月及12个月时，采用改良版美国公共卫生署（United States Public Health Service, USPHS）评分标准，从固位性、边缘着色、边缘密合性、术后敏感性、表面质地及配色匹配度六个维度对修复体进行评分。统计分析采用卡方检验、McNemar检验及Kaplan-Meier生存分析完成。

研究结果
术后12个月时，受试者召回率为87%。CN组与GP组修复体的12个月留存率分别为92.5%与97.7%。其中3颗CN组修复体与1颗GP组修复体出现固位丢失。17.9%（7颗）的CN组修复体及11.6%（5颗）的GP组修复体边缘密合性评分被评为bravo级，两组间差异无统计学意义（p=0.363）。边缘着色方面，CN组2.7%（1颗）与GP组4.7%（2颗）的修复体被评为bravo级，两组间差异无统计学意义（p=1.00）。表面质地维度，CN组8.1%（3颗）与GP组7.0%（3颗）的修复体被评为bravo级，两组间差异无统计学意义（p=1.00）。所有随访节点均未观察到修复术后敏感性或继发龋。

研究结论
受试的两款修复材料在术后12个月时展现出相近的临床修复效果。
临床试验注册号：ClinicalTrials.gov（NTC04825379）