含窝沟封闭剂的 giomer S-PRG 填料的保留率：一项随机临床试验。

Retention rate of giomer S-PRG filler containing pit and fissure sealant applied with or without etching: a randomized clinical trial.

机构信息

Department of Conservative Dentistry, Faculty of Dentistry, Cairo University, Cairo, Egypt.

出版信息

BMC Oral Health. 2024 Nov 7;24(1):1356. doi: 10.1186/s12903-024-05096-7.

DOI:10.1186/s12903-024-05096-7

PMID:39511504

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11546273/

Abstract

BACKGROUND

Pit and fissure sealant is a micro-invasive modality for treating deep and retentive pits and fissures to prevent and/or stop occlusal caries. Every effort needs to be done to enhance sealant retention and survival. The aim of this research is to assess the retention rate of giomer S-PRG filler containing pit and fissure sealant applied with or without etching.

METHODS

Overall, 52 patients were included in this trial and they were allocated randomly in 2 groups (n = 26). Group 1 (control group) received giomer sealant (Beautisealant, Shofu, Kyoto, Japan) without an etching step, and group 2 (intervention group) received the same but with a separate preparatory etching step before the sealant application. The retention rate of the sealant was assessed over one year at 3 months, 6 months, and 12 months. Intergroup comparison between categorical variables was done using the chi square test, while intragroup comparison was done using Cochran's q test followed by multiple comparisons. Relative risk was used to evaluate the clinical significance. Survival rate was analyzed using Kaplan-meier and Log-rank test.

RESULTS

Intergroup comparison between both techniques revealed statistically significant difference within different follow up periods (P < 0.05). Intragroup comparison within both giomer sealant with etching group and giomer sealant without etching group revealed statistically significant difference between different follow-up periods (P < 0.001). There was 69% less risk for total loss or partial loss of giomer sealant with etching when compared to giomer sealant without etching after 12 months.

CONCLUSION

An initial preparatory step of etching to the enamel surface is crucial before giomer sealant application to enhance its bonding, increase its retention and promote its survival.

TRIAL REGISTRATION

Trial registration ClinicalTrials.gov, NCT04929782. Registered 14 July 2024 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06509451.

摘要

背景

窝沟封闭剂是一种微创方法，用于治疗深而滞留的窝沟，以预防和/或停止窝沟龋。需要尽一切努力来提高封闭剂的保留率和存活率。本研究旨在评估含牙本质 S-PRG 填料的窝沟封闭剂的保留率，该封闭剂应用于或不应用蚀刻。

方法

共有 52 名患者参与了这项试验，他们被随机分为两组（n=26）。第 1 组（对照组）接受 giomer 密封剂（Beautisealant，Shofu，Kyoto，日本），而不进行蚀刻步骤，第 2 组（干预组）接受相同的密封剂，但在应用密封剂前进行单独的预备蚀刻步骤。在一年的时间里，分别在 3 个月、6 个月和 12 个月评估封闭剂的保留率。使用卡方检验对分类变量进行组间比较，使用 Cochran's q 检验和随后的多重比较进行组内比较。相对风险用于评估临床意义。使用 Kaplan-Meier 和 Log-rank 检验分析生存率。

结果

两种技术之间的组间比较在不同的随访期间显示出统计学上的显著差异（P<0.05）。giomer 密封剂加蚀刻组和 giomer 密封剂不加蚀刻组的组内比较在不同的随访期间显示出统计学上的显著差异（P<0.001）。与 giomer 密封剂不加蚀刻相比，在 12 个月后，giomer 密封剂加蚀刻的总损失或部分损失风险降低了 69%。