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Clinical Trials/NCT04616469
NCT04616469CompletedPhase 4

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

Cairo University2 sites in 1 country40 target enrollmentStarted: May 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Post operative pain using visual analogue scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

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

  • time required for the instrument to reach the full working length(during treatment)
  • operative torque generated during instrumentation(during treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tarek Ali El Mosalamy

Doctor

Cairo University

Study Sites (2)

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