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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07714733
Enrollment
120
Registered
2026-07-20
Start date
2026-07-20
Completion date
2027-03-15
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Postoperative Pain After Endodontic Treatment

Keywords

Endodontics, Root Canal Treatment, Postoperative Pain, Apical Motion, Rotary Nicel Titanium File, Reciprocating Nickel-Titanium File

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.

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

PROCEDURERoot Canal Treatment

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.

DEVICEAuto Apical Stop Mode

Endodontic motor operated with the auto apical stop mode activated.

DEVICEAuto Apical Reverse Mode

Endodontic motor operated with the auto apical reverse mode activated.

DEVICEApical Off Mode

Endodontic motor operated with the apical action mode turned off.

Sponsors

Alanya Alaaddin Keykubat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

Participants will be randomly assigned in a 1:1:1:1:1:1 ratio to one of six parallel treatment groups according to the instrumentation kinematics (rotary or reciprocating) and apical motion mode (auto apical stop, auto apical reverse, or off mode).

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain IntensityRepeated 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.

Secondary

MeasureTime frameDescription
Analgesic IntakeWithin 7 days after treatmentAnalgesic intake will be assessed as the total number of analgesic tablets taken by each participant during the first 7 days after treatment.

Contacts

CONTACTMehmet Sinan SİNECAN, Research Assistant
sinan.sinecan@alanya.edu.tr90 507 059 81 62
PRINCIPAL_INVESTIGATORHatice BÜYÜKÖZER ÖZKAN, Associate Professor

Alanya Alaaddin Keykubat University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026