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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Root canal treatment using race rotary instruments; Procedure: Root canal treatment using TruNaomy rotary files

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Root canal treatment using RaCe rotary system; Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity	Procedure: Root canal treatment using race rotary instruments; Race rotary files will be used for the process of cleaning and shaping of the root canal system
Experimental: Root canal treatment using TruNatomy rotary system; Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity	Procedure: Root canal treatment using TruNaomy rotary files; Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain using visual analogue scale	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	at 24 hours post treatment
Post operative pain using visual analogue scale	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	at 48 hours post treatment
Post operative pain using visual analogue scale	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	at 72 hours post treatment
Post operative pain using visual analogue scale	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	at 1 week post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative torque generated during instrumentation	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	during treatment
time required for the instrument to reach the full working length	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	during treatment

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Gambarini G, Galli M, Seracchiani M, Di Nardo D, Versiani MA, Piasecki L, Testarelli L. In Vivo Evaluation of Operative Torque Generated by Two Nickel-Titanium Rotary Instruments during Root Canal Preparation. Eur J Dent. 2019 Oct;13(4):556-562. doi: 10.1055/s-0039-1698369. Epub 2019 Dec 31.
• Zand V, Milani AS, Hassani Dehkharghani A, Rahbar M, Tehranchi P. Treatment of Necrotic Teeth Using Two Engine-Driven Systems and Patient's Postoperative Pain: A Double-Blind Clinical Trial. Iran Endod J. 2016 Fall;11(4):267-272. doi: 10.22037/iej.2016.3.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: ENDO:3-3-5 (8-10-2020)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No