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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Root Canal Treatment
  Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
• Устройство Rotary Instrumentation
  Canal preparation performed using continuous rotary motion.
• Устройство Reciprocating Instrumentation
  Canal preparation performed using reciprocating motion.
• Устройство Auto Apical Stop Mode
  Endodontic motor operated with the auto apical stop mode activated.
• Устройство Auto Apical Reverse Mode
  Endodontic motor operated with the auto apical reverse mode activated.
• Устройство Apical Off Mode
  Endodontic motor operated with the apical action mode turned off.

Первичные конечные точки

• Postoperative Pain Intensity [Срок оценки: Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.]

Вторичные конечные точки (1)

• Analgesic Intake [Срок оценки: Within 7 days after treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Tulgar MM, Kilic Y, Karalar O, Yilmaz HE, Karataslioglu E. Inflammatory Mediator Levels and Postoperative Pain Following Root Canal Shaping with Different Apical Actions: A Randomized Controlled Trial. J Endod. 2026 Apr;52(4):574-581.e1. doi: 10.1016/j.joen.2025.12.005. Epub 2025 Dec 23. PMID 41448536
• Mendes WV, Lima SNL, do Nascimento Azevedo JV, Leite HLA, Oliveira PS, Ferreira MC, Carvalho CN. Postoperative pain and quality of life assessment after endodontic preparation with rotary and reciprocating endodontic instruments: randomized clinical trial. Trials. 2025 Feb 26;26(1):68. doi: 10.1186/s13063-025-08766-1. PMID 40001136
• Govindiah Chandra Mohan BG, Shivakumar D, Laxmi Penumaka S, Althaf S, Garg G, Kamatchi Subramani S. To Evaluate Different Endodontic Instrumentation Systems Regarding Post-Operative Pain After Endodontic Therapy: A Clinical Study. Cureus. 2024 Mar 19;16(3):e56466. doi: 10.7759/cureus.56466. eCollection 2024 Mar. PMID 38638716

Идентификаторы

NCT: NCT07714733 · ALKU-EC-2026-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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