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

July 16, 2026 updated by: Hatice BÜYÜKÖZER ÖZKAN, Alanya Alaaddin Keykubat University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotary + Apical Stop
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated.
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: Auto Apical Stop Mode
Endodontic motor operated with the auto apical stop mode activated.
Experimental: Rotary + Apical Reverse
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated.
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: Auto Apical Reverse Mode
Endodontic motor operated with the auto apical reverse mode activated.
Experimental: Rotary + Apical Off
Participants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off.
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: Apical Off Mode
Endodontic motor operated with the apical action mode turned off.
Experimental: Reciprocating + Apical Stop
Participants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated.
Procedure: Root Canal Treatment
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Device: Auto Apical Stop Mode
Endodontic motor operated with the auto apical stop mode activated.
Device: Reciprocating Instrumentation
Canal preparation performed using reciprocating motion.
Experimental: Reciprocating + Apical Reverse
Participants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated.
Procedure: Root Canal Treatment
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Device: Auto Apical Reverse Mode
Endodontic motor operated with the auto apical reverse mode activated.
Device: Reciprocating Instrumentation
Canal preparation performed using reciprocating motion.
Experimental: Reciprocating + Apical Off
Participants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off.
Procedure: Root Canal Treatment
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Device: Apical Off Mode
Endodontic motor operated with the apical action mode turned off.
Device: Reciprocating Instrumentation
Canal preparation performed using reciprocating motion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Intake
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alanya Alaaddin Keykubat University

Investigators

  • Principal Investigator: Hatice BÜYÜKÖZER ÖZKAN, Associate Professor, Alanya Alaaddin Keykubat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKU-EC-2026-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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