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
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
July 20, 2026
CompletedStudy Start
First participant enrolled
July 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2027
July 20, 2026
July 1, 2026
7 months
March 11, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Intensity
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.
Secondary Outcomes (1)
Analgesic Intake
Within 7 days after treatment
Study Arms (6)
Rotary + Apical Stop
EXPERIMENTALParticipants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated.
Rotary + Apical Reverse
EXPERIMENTALParticipants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated.
Rotary + Apical Off
EXPERIMENTALParticipants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off.
Reciprocating + Apical Stop
EXPERIMENTALParticipants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated.
Reciprocating + Apical Reverse
EXPERIMENTALParticipants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated.
Reciprocating + Apical Off
EXPERIMENTALParticipants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off.
Interventions
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.
Canal preparation performed using reciprocating motion.
Endodontic motor operated with the auto apical reverse mode activated.
Endodontic motor operated with the apical action mode turned off.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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: 41448536BACKGROUNDMendes 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: 40001136BACKGROUNDGovindiah 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: 38638716BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatice BÜYÜKÖZER ÖZKAN, Associate Professor
Alanya Alaaddin Keykubat University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and the outcome assessor will be blinded to group allocation. Due to the nature of the intervention, the operator performing the root canal treatment cannot be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2026
First Posted
July 20, 2026
Study Start
July 20, 2026
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
March 15, 2027
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.