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
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mehmet Sinan SİNECAN, Research Assistant
- Telefonnummer: 90 507 059 81 62
- E-post: sinan.sinecan@alanya.edu.tr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Rotary + Apical Stop
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated.
|
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.
|
|
Experimentell: Rotary + Apical Reverse
Participants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated.
|
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 reverse mode activated.
|
|
Experimentell: Rotary + Apical Off
Participants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off.
|
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 apical action mode turned off.
|
|
Experimentell: Reciprocating + Apical Stop
Participants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated.
|
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Endodontic motor operated with the auto apical stop mode activated.
Canal preparation performed using reciprocating motion.
|
|
Experimentell: Reciprocating + Apical Reverse
Participants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated.
|
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Endodontic motor operated with the auto apical reverse mode activated.
Canal preparation performed using reciprocating motion.
|
|
Experimentell: Reciprocating + Apical Off
Participants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off.
|
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Endodontic motor operated with the apical action mode turned off.
Canal preparation performed using reciprocating motion.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Pain Intensity
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Analgesic Intake
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Hatice BÜYÜKÖZER ÖZKAN, Associate Professor, Alanya Alaaddin Keykubat University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ALKU-EC-2026-39
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .