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《根管再治疗术后疼痛的 GuttaClear 治疗效果:一项随机临床试验》

Effect of GuttaClear on Postoperative Pain After Root Canal Retreatment: A Randomized Clinical Trial.

机构信息

Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.

Dental Biomaterial Analysis and Research Center, Research Service Section, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.

出版信息

Eur Endod J. 2023 Jan;8(1):55-64. doi: 10.14744/eej.2022.85047.

Abstract

OBJECTIVE

The aim of this study was to evaluate postoperative pain after non-surgical root canal retreatment with or without GuttaClear.

METHODS

Sixty participants were randomly distributed in this non-inferiority trial into two parallel singleblinded experimental groups (Group1: non-solvent, Group2: solvent). After root canal retreatment, the participants completed questionnaires using direct (numerical rating scales) and indirect (number of analgesics taken) measurements of postoperative pain at immediate, 6, 12, 24, 48, and 72 h post-retreatment. The predisposing postoperative pain factors were recorded and analysed using Generalized Estimating Equations to identify correlated factors (α=0.05).

RESULTS

The pain incidence was not significantly different between the groups at any time point. The highest incidence of postoperative pain occurred immediately after retreatment (35%) and then decreased to 15% at 24 h (P<0.05). The number of participants requiring analgesics was 6.67% in the non-solvent group and 9.99% in the solvent group which were similar between the groups. Patients with a history of previous postoperative pain were 21.6-fold more likely to have postoperative pain than those without (P<0.05).

CONCLUSION

There was no difference in postoperative pain or analgesics required after root canal retreatment with or without using GuttaClear. This study is registered in ClinicalTrial.gov (NCT04326998). (EEJ-2022-05-069).

摘要

目的

本研究旨在评估非手术根管再治疗中使用或不使用 GuttaClear 后的术后疼痛。

方法

本非劣效性试验将 60 名参与者随机分为两组平行的单盲实验组(组 1:无溶剂,组 2:溶剂)。根管再治疗后,参与者使用直接(数字评分量表)和间接(服用止痛药的数量)测量方法,在治疗后即刻、6、12、24、48 和 72 小时评估术后疼痛,并填写问卷。使用广义估计方程记录和分析易感术后疼痛的因素,以确定相关因素(α=0.05)。

结果

两组在任何时间点的疼痛发生率均无显著差异。再治疗后即刻疼痛发生率最高(35%),24 小时后降至 15%(P<0.05)。需要止痛药的参与者在无溶剂组为 6.67%,在溶剂组为 9.99%,两组之间相似。有既往术后疼痛史的患者发生术后疼痛的可能性是非疼痛史患者的 21.6 倍(P<0.05)。

结论

使用或不使用 GuttaClear 进行根管再治疗后的术后疼痛或所需的止痛药无差异。本研究已在 ClinicalTrials.gov 注册(NCT04326998)。(EEJ-2022-05-069)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2a1/10098468/dd8348f0bf73/EEJ-8-055-g001.jpg

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