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

NCT04616469 | Completed Phase 4 DMC

• 1 other identifier: ENDO:3-3-5 (8-10-2020)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• operative torque generated during instrumentation

  during treatment

• time required for the instrument to reach the full working length

  during treatment

Study Arms (2)

Root canal treatment using RaCe rotary system

ACTIVE COMPARATOR

Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity

Procedure: Root canal treatment using race rotary instruments

Root canal treatment using TruNatomy rotary system

EXPERIMENTAL

Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity

Procedure: Root canal treatment using TruNaomy rotary files

Interventions

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 TruNatomy rotary 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

Root canal treatment using RaCe rotary system

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11553, Egypt

Location

Related Publications (3)

• 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.

  PMID: 31891973 BACKGROUND

• 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.

  PMID: 27790254 BACKGROUND

• Al-Mosalmy TA, El-Far HM, Gomaa MM, Morsy DA. Impact of root canal shaping using TruNatomy on postoperative pain and operative torque generation: a randomized clinical trial. BMC Oral Health. 2025 Jul 19;25(1):1222. doi: 10.1186/s12903-025-06418-z.

  PMID: 40684114 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 5, 2020
• Study Start: May 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

EG (1)