Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain (TRN)

July 18, 2022 updated by: Nora El-Sayed Khater, Cairo University

Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.

The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

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 Backup

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

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 25 - 45 years old.
  2. Males or Females.

  3. Mandibular molar teeth with:

    • No pain.
    • No response to pulp testing.
    • Radiographic appearance with or without a periapical radiolucency.

Exclusion Criteria:

  1. Patients with pre-operative pain.
  2. Patients having significant systemic disorders.
  3. Patients who are allergic to non-steroidal anti-inflammatory drugs.
  4. Patients with two or more adjacent teeth requiring root canal therapy.

  5. Teeth that have:

    • Vital pulp tissues.
    • Association with swelling or fistulous tract.
    • Acute or chronic peri-apical abscess.
    • Greater than grade I mobility.
    • Pocket depth greater than 5mm.
    • No possible restorability.
    • Previous endodontic treatment.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TruNatomy Files
Newly introduced endodontic file
Device: TruNatomy Files
Newly introduced endodontic file with high flexibility.
Experimental: Hyflex EDM
Endodontic file
Device: HyFlex EDM Files
Endodontic files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain
Time Frame: Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.
The pain will be recorded according to the modified visual analogue scale. The scale consists of a line marked from 1 to 10 where 10 represent the most intense pain imaginable and the worst outcome.
Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesics taken by the patient after endodontic treatment
Time Frame: up to 7 days post-operatively
Counting Number of analgesics taken by the patient after endodontic treatment
up to 7 days post-operatively

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Angie Ghoneim, PHD, 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 (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRN in postoperative pain

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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