Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
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.
Обзор исследования
Статус
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Mehmet Sinan SİNECAN, Research Assistant
- Номер телефона: 90 507 059 81 62
- Электронная почта: sinan.sinecan@alanya.edu.tr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative Pain Intensity
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Analgesic Intake
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Hatice BÜYÜKÖZER ÖZKAN, Associate Professor, Alanya Alaaddin Keykubat University
Публикации и полезные ссылки
Общие 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Боль
- Неврологические проявления
- Заболевания пародонта
- Заболевания полости рта
- Стоматогнатические заболевания
- Послеоперационные осложнения
- Патологические процессы
- Периапикальные заболевания
- Заболевания челюсти
- Пародонтит
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Боль, Послеоперационный
- Периапикальный периодонтит
Другие идентификационные номера исследования
- ALKU-EC-2026-39
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .