An interventional study of Root Canal Treatment and Rotary Instrumentation in Apical Periodontitis and Postoperative Pain After Endodontic Treatment, sponsored by Alanya Alaaddin Keykubat University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Alanya Alaaddin Keykubat University · Not applicable, Interventional, and 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.
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.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Alanya Alaaddin Keykubat University is the lead sponsor of 51 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated.
Procedure: Root Canal Treatment · Device: Rotary Instrumentation · Device: Auto Apical Stop Mode
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated.
Procedure: Root Canal Treatment · Device: Rotary Instrumentation · Device: Auto Apical Reverse Mode
Participants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off.
Procedure: Root Canal Treatment · Device: Rotary Instrumentation · Device: Apical Off Mode
Participants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated.
Procedure: Root Canal Treatment · Device: Reciprocating Instrumentation · Device: Auto Apical Stop Mode
Participants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated.
Procedure: Root Canal Treatment · Device: Reciprocating Instrumentation · Device: Auto Apical Reverse Mode
Participants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off.
Procedure: Root Canal Treatment · Device: Reciprocating Instrumentation · Device: Apical Off Mode
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Canal preparation performed using continuous rotary motion.
Canal preparation performed using reciprocating motion.
Endodontic motor operated with the auto apical stop mode activated.
Endodontic motor operated with the auto apical reverse mode activated.
Endodontic motor operated with the apical action mode turned off.
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.
Time frame: Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.
Analgesic Intake
Analgesic intake will be assessed as the total number of analgesic tablets taken by each participant during the first 7 days after treatment.
Time frame: Within 7 days after treatment
Plan to share: No — 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.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Of 171 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 6 months is below that.
Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: start Jul 2026 → Aug 2026, primary completion Feb 2027 → Mar 2027 and completion Mar 2027 → Apr 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Alanya Alaaddin Keykubat University