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使用旋转和往复式牙髓器械进行根管预备后的术后疼痛及生活质量评估:随机临床试验

Postoperative pain and quality of life assessment after endodontic preparation with rotary and reciprocating endodontic instruments: randomized clinical trial.

作者信息

Mendes Wallace Vieira, Lima Suellen Nogueira Linares, do Nascimento Azevedo Jacqueline Vitória, Leite Hadda Lyzandra Austríaco, Oliveira Patrícia Santos, Ferreira Meire Coelho, Carvalho Ceci Nunes

机构信息

UniCEUMA: Universidade Ceuma, São Luís, 125287, Brazil.

Postgraduate Program of Dentistry, CEUMA University, São Luís, Brazil.

出版信息

Trials. 2025 Feb 26;26(1):68. doi: 10.1186/s13063-025-08766-1.

Abstract

BACKGROUND

Postoperative pain is a common complication following endodontic treatment, often caused by acute inflammatory responses in the periapical tissues. Several factors contribute to this, including inadequate instrumentation, apical extrusion of debris during canal preparation, and other aspects of the procedure. Advances in technology have led to the development of nickel-titanium (NiTi) instruments that have shown potential to reduce postoperative discomfort. The purpose of this study was to evaluate postoperative pain in patients undergoing endodontic treatment with different NiTi systems.

METHODS

This randomized clinical trial will include 128 patients between the ages of 18 and 50 years with a diagnosis of pulp changes in molars without pain or radiographic lesions requiring endodontic treatment. Patients will be randomized to receive root canal preparation with the rotary ProTaper Ultimate rotary system or the Reciproc Blue reciprocating single-file system. The primary outcome will be the intensity of postoperative pain measured by a numerical rating scale (NRS-10 cm) in 24 h postoperatively. Secondary outcomes will include the intensity of postoperative pain measured by a visual analog scale (VAS-0-10 cm) at 6 and 12 h and spontaneous pain, occlusion sensitivity, and quality of life, assessed by the OHIP-14 questionnaire.

DISCUSSION

Our null hypothesis is that there will be no significant difference in postoperative pain between the two systems. The results of this study will provide information on the incidence and intensity of postoperative pain after instrumentation of root canal instrumentation with different NiTi systems and may help improve patient outcomes and quality of life.

TRIAL REGISTRATION

Brazilian Clinical Trials Registry (REBEC): RBR-10kbw6nx. Registered on April 6, 2024.

摘要

背景

术后疼痛是根管治疗后常见的并发症,通常由根尖周组织的急性炎症反应引起。多种因素导致这一情况,包括器械预备不充分、根管预备过程中碎屑的根尖挤出以及该操作的其他方面。技术的进步促使了镍钛(NiTi)器械的发展,这些器械已显示出减轻术后不适的潜力。本研究的目的是评估使用不同NiTi系统进行根管治疗的患者的术后疼痛情况。

方法

这项随机临床试验将纳入128名年龄在18至50岁之间、诊断为磨牙牙髓改变但无疼痛或影像学病变且需要根管治疗的患者。患者将被随机分配接受使用旋转ProTaper Ultimate旋转系统或Reciproc Blue往复单根管系统进行根管预备。主要结局将是术后24小时通过数字评分量表(NRS - 10厘米)测量的术后疼痛强度。次要结局将包括术后6小时和12小时通过视觉模拟量表(VAS - 0至10厘米)测量的术后疼痛强度,以及通过OHIP - 14问卷评估的自发痛、咬合敏感度和生活质量。

讨论

我们的零假设是两种系统在术后疼痛方面无显著差异。本研究的结果将提供关于使用不同NiTi系统进行根管预备后术后疼痛的发生率和强度的信息,并可能有助于改善患者的预后和生活质量。

试验注册

巴西临床试验注册中心(REBEC):RBR - 10kbw6nx。于2024年4月6日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/135d/11863933/11721bc9a5ad/13063_2025_8766_Fig1_HTML.jpg

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