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

16. juli 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Eksperimentel: 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.
Eksperimentel: 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.
Eksperimentel: 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.
Eksperimentel: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Intensity
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Analgesic Intake
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hatice BÜYÜKÖZER ÖZKAN, Associate Professor, Alanya Alaaddin Keykubat University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

15. februar 2027

Studieafslutning (Anslået)

15. marts 2027

Datoer for studieregistrering

Først indsendt

11. marts 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Apikal parodontitis

Kliniske forsøg med Root Canal Treatment

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