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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04616469
Enrollment
40
Registered
2020-11-05
Start date
2023-05-01
Completion date
2024-07-01
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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

Interventions

PROCEDURERoot canal treatment using TruNaomy rotary files

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

PROCEDURERoot canal treatment using race rotary instruments

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain using visual analogue scaleat 24 hours post treatmentpain 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

MeasureTime frameDescription
operative torque generated during instrumentationduring treatmentreal 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
time required for the instrument to reach the full working lengthduring treatmenttime required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026