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

April 14, 2025 updated by: Tarek Ali El Mosalamy, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt, 11553
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at 24 hours post treatment
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
at 48 hours post treatment
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
at 72 hours post treatment
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
at 1 week post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
during treatment
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
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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