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Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment

2026年7月16日 更新者:Hatice BÜYÜKÖZER ÖZKAN、Alanya Alaaddin Keykubat University

The Effect of Using A Single Nickel-Titanium File System With Rotary And Reciprocation Kinematics in Different Apical Motion Modes on Postoperative Pain After Root Canal Treatment

Brief Summary

This prospective, randomized clinical trial aims to evaluate the effect of different endodontic motor settings used during root canal treatment on postoperative pain.

During root canal treatment, the inner part of the tooth is cleaned and shaped using specialized rotating instruments. These instruments can operate with different motion patterns, and the motor may respond differently as the instrument approaches the tip of the root. The influence of these technical variations on postoperative pain has not been clearly established.

Adult participants requiring root canal treatment for mandibular premolar teeth will be enrolled in the study. Participants will be randomly assigned to different groups. In each group, root canal treatment will be performed using different motor motion settings. All procedures applied in this study are routine and safe treatment methods commonly used in clinical endodontic practice.

After treatment, participants' pain levels will be monitored through telephone follow-ups. Pain intensity will be assessed using the Visual Analog Scale (VAS). In addition, analgesic intake will be recorded.

The purpose of this study is to determine whether different endodontic motor settings influence postoperative pain and patient comfort following root canal treatment. The findings are expected to contribute to safer and more comfortable root canal treatment protocols.

研究概览

详细说明

Detailed Description

Postoperative pain remains one of the most relevant short-term outcomes in endodontic treatment and may be influenced by several mechanical and biological factors during root canal preparation. Among these factors, the kinematics of nickel-titanium instrumentation systems and the apical motion algorithms integrated into endodontic motors may affect debris extrusion, apical stress, and periapical tissue irritation. Although different motor settings are routinely used in clinical practice, the influence of these apical motion modes on postoperative pain has not been sufficiently clarified.

This prospective, randomized, double-blind clinical trial is designed to investigate the effect of different apical motion algorithms used during root canal treatment on postoperative pain. The study will focus on mandibular premolar teeth diagnosed with chronic apical periodontitis and requiring primary root canal treatment. Participants will be randomly assigned to one of six treatment groups according to the kinematic system used during canal preparation (rotary or reciprocating) and the apical motion mode of the endodontic motor (auto apical stop, auto apical reverse, or off mode).

All treatments will be performed by the investigator using a standardized clinical protocol under local anesthesia and rubber dam isolation. Working length determination, irrigation, ultrasonic activation, canal preparation, obturation, and coronal restoration procedures will be standardized in order to minimize operator- and technique-related variability. A single nickel-titanium file system will be used in all groups to reduce the confounding effect of instrument design.

The main purpose of this study is to determine whether the use of different apical motion modes, under rotary and reciprocating kinematics, results in differences in postoperative pain intensity. In addition, the study seeks to provide clinically relevant evidence regarding whether these motor settings influence patient comfort after treatment. The findings are expected to contribute to the optimization of endodontic instrumentation protocols and to support more evidence-based selection of motor settings in daily clinical practice.

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

描述

Inclusion Criteria:

  • Adults aged 18-70 years
  • Systemically healthy individuals (ASA I)
  • Mandibular premolar teeth diagnosed with chronic apical periodontitis
  • Periapical Index (PAI) score ≥ 3 confirmed radiographically
  • Teeth indicated for single-visit root canal treatment
  • Patients able to understand and complete the Visual Analog Scale (VAS)
  • Written informed consent provided

Exclusion Criteria:

  • Patients with systemic diseases or medically compromised conditions
  • Pregnant or breastfeeding women
  • Patients with uncontrolled diabetes mellitus
  • Use of analgesics or antibiotics within the previous 7 days
  • Teeth with root resorption
  • Teeth with immature apices
  • Previously endodontically treated teeth
  • Patients unable to provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Rotary + Apical Stop
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated.
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Canal preparation performed using continuous rotary motion.
Endodontic motor operated with the auto apical stop mode activated.
实验性的:Rotary + Apical Reverse
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated.
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Canal preparation performed using continuous rotary motion.
Endodontic motor operated with the auto apical reverse mode activated.
实验性的:Rotary + Apical Off
Participants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off.
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Canal preparation performed using continuous rotary motion.
Endodontic motor operated with the apical action mode turned off.
实验性的:Reciprocating + Apical Stop
Participants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated.
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Endodontic motor operated with the auto apical stop mode activated.
Canal preparation performed using reciprocating motion.
实验性的:Reciprocating + Apical Reverse
Participants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated.
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Endodontic motor operated with the auto apical reverse mode activated.
Canal preparation performed using reciprocating motion.
实验性的:Reciprocating + Apical Off
Participants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off.
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Endodontic motor operated with the apical action mode turned off.
Canal preparation performed using reciprocating motion.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative Pain Intensity
大体时间:Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater postoperative pain intensity. The same outcome measure will be assessed repeatedly at predefined postoperative time points to evaluate changes in postoperative pain intensity over time.
Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.

次要结果测量

结果测量
措施说明
大体时间
Analgesic Intake
大体时间:Within 7 days after treatment
Analgesic intake will be assessed as the total number of analgesic tablets taken by each participant during the first 7 days after treatment.
Within 7 days after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hatice BÜYÜKÖZER ÖZKAN, Associate Professor、Alanya Alaaddin Keykubat University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月20日

初级完成 (估计的)

2027年2月15日

研究完成 (估计的)

2027年3月15日

研究注册日期

首次提交

2026年3月11日

首先提交符合 QC 标准的

2026年7月16日

首次发布 (实际的)

2026年7月20日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Individual participant data will not be shared due to ethical restrictions, institutional policies, and the requirements of the Turkish Personal Data Protection Law (Law No. 6698, KVKK). Participant confidentiality will be strictly protected, and the collected data will be used solely for the purposes of the approved study protocol.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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