Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation

Last updated: April 14, 2025
Sponsor: Cairo University
Overall Status: Completed

Phase

4

Condition

Pain

Post-surgical Pain

Chronic Pain

Treatment

Root canal treatment using race rotary instruments

Root canal treatment using TruNaomy rotary files

Clinical Study ID

NCT04616469
ENDO:3-3-5 (8-10-2020)
  • Ages 30-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:

  • Post operative pain: incidence and intensity

  • Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor

  • Time needed for the instruments to reach to the full working length

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are free from any physical or mental handicapping condition and nocontributory systemic disease.

  • Age between 30-60 years old.

  • Males & Females.

  • Patients' acceptance for participating in the trial through an informed consent

  • Maxillary permanent premolar teeth:

  • Diagnosed clinically and radiographically with pulp necrosis

  • With or without periapical radiolucency

  • Negative response of pulp tissue to thermal and electric pulp tester

  • Possessing two independent roots each having a type I canal

  • Patent canals with no internal calcification or resorptive lesions

  • Fully formed roots

  • Root curvatures less than 30

Exclusion

Exclusion Criteria:

  • Patient with contributory medical condition

  • Badly destructed teeth

  • Patients with pre-operative pain

  • Patients having significant systemic disorders

  • Patients with two or more adjacent teeth requiring root canal therapy

  • Patients who had received antibiotics in the last month

  • Teeth presenting with:

  • Positive response to thermal or electric pulp tester

  • History of trauma or previous endodontic treatment

  • Immature or open apices

  • Association with acute periapical abscess and swelling or fistulous tract

  • Fused roots at any level

  • Canals larger than size 15# K-file

  • Periodontonal/ endodontic lesions

  • Mobility higher than grade I

  • Radiographic evidence of external or internal root resorption vertical rootfracture, perforation, calcification.

  • Severe root curvature (>30)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Root canal treatment using race rotary instruments
Phase: 4
Study Start date:
May 01, 2023
Estimated Completion Date:
July 01, 2024

Connect with a study center

  • Cairo University

    Cairo, 11553
    Egypt

    Site Not Available

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