Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Root Canal Treatment, Rotary Instrumentation, Reciprocating Instrumentation, Auto Apical Stop Mode.
- Who it may be relevant to
- Registry conditions: Apical Periodontitis, Postoperative Pain After Endodontic Treatment. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Procedure Root Canal Treatment
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation. - Device Rotary Instrumentation
Canal preparation performed using continuous rotary motion. - Device Reciprocating Instrumentation
Canal preparation performed using reciprocating motion. - Device Auto Apical Stop Mode
Endodontic motor operated with the auto apical stop mode activated. - Device Auto Apical Reverse Mode
Endodontic motor operated with the auto apical reverse mode activated. - Device Apical Off Mode
Endodontic motor operated with the apical action mode turned off.
Primary outcome measures
- Postoperative Pain Intensity [Time frame: Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.]
Secondary outcome measures (1)
- Analgesic Intake [Time frame: Within 7 days after treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07714733 · ALKU-EC-2026-39