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基于 alkasite 的生物活性修复材料在 II 类窝洞中的临床性能:一项随机临床试验。

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

机构信息

Hacettepe University, School of Dentistry, Department of Restorative Dentistry, Ankara, Turkey.

出版信息

J Appl Oral Sci. 2023 Jun 23;31:e20230025. doi: 10.1590/1678-7757-2023-0025. eCollection 2023.

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

目的

本临床研究旨在通过比较基于 alkasite 的生物活性材料与树脂复合材料(RC)在一年内修复 II 类腔的临床性能,来评估一种基于 alkasite 的生物活性材料的临床性能。

方法

在 31 名参与者中,共修复了 100 个 II 类腔。分组如下:Cention N(CN)(Ivoclar Vivadent,列支敦士登 Schaan)和 G-ænial Posterior(GP)(GC,日本东京)与 G-Premio Bond(酸蚀&冲洗)联合使用。根据制造商的说明应用修复系统。放置后立即进行修整和抛光,并在第 1 周(基线)、6 个月和 12 个月后,根据保留、边缘变色、边缘适应性、敏感性、表面纹理和颜色匹配使用改良的 USPHS 标准进行评分。使用卡方检验、McNemar 检验和 Kaplan-Meier 检验进行统计学分析。

结果

12 个月后,召回率为 87%。CN 和 GP 修复体的存活率分别为 92.5%和 97.7%。三个 CN 和一个 GP 修复体失去保留。七个 CN(17.9%)和五个 GP(11.6%)修复体的边缘适应性评分为 Bravo,两组间无显著差异(p=0.363)。一个 CN(2.7%)和两个 GP(4.7%)修复体的边缘变色评分为 Bravo,但两组间无显著差异(p=1.00)。对于表面纹理,三个 CN(8.1%)和三个 GP(7%)修复体的评分为 Bravo(p=1.00)。在任何检查中,均未发现修复体有术后敏感性或继发龋。

结论

在 12 个月后,测试的修复材料表现出相似的成功临床性能。ClinicalTrials.gov(NTC04825379)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46b9/10343945/7fb5c805dbd0/1678-7757-jaos-31-e20230025-gf01.jpg

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