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Completed

NCT Number: NCT04616469

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

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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, 11553, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are free from any physical or mental handicapping condition and no contributory 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 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 root fracture, perforation, calcification.
  • Severe root curvature (>30)

Treatment and study plan

Root canal treatment using TruNaomy rotary files

Procedure

Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system

Root canal treatment using race rotary instruments

Procedure

Race rotary files will be used for the process of cleaning and shaping of the root canal system

Primary outcomes

  1. Post operative pain using visual analogue scale

    Time frame: at 24 hours post treatment

    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible

  2. Post operative pain using visual analogue scale

    Time frame: at 48 hours post treatment

    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible

  3. Post operative pain using visual analogue scale

    Time frame: at 72 hours post treatment

    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible

  4. Post operative pain using visual analogue scale

    Time frame: at 1 week post treatment

    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible

Secondary outcomes

  1. operative torque generated during instrumentation

    Time frame: during treatment

    real time operative torque exerted on the instrument through out the shaping process and until the instrument reaches the full working length will be measured using a torque measuring motor in real time

  2. time required for the instrument to reach the full working length

    Time frame: during treatment

    time required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2020
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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