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

Primary Purpose

Endodontically Treated Teeth

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

TruNatomy Files

HyFlex EDM Files

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 25 - 45 years old.
Males or Females.
Mandibular molar teeth with:
- No pain.
- No response to pulp testing.
- Radiographic appearance with or without a periapical radiolucency.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TruNatomy Files

Hyflex EDM

Arm Description

Newly introduced endodontic file

Endodontic file

Outcomes

Primary Outcome Measures

Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain

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.

Secondary Outcome Measures

Number of analgesics taken by the patient after endodontic treatment

Counting Number of analgesics taken by the patient after endodontic treatment

Full Information

NCT ID

NCT05289973

First Posted

December 22, 2021

Last Updated

July 18, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05289973

Brief Title

Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

Acronym

TRN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2022 (Anticipated)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endodontically Treated Teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

patients having mandibular molars with necrotic pulp

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TruNatomy Files

Arm Type

Experimental

Arm Description

Newly introduced endodontic file

Arm Title

Hyflex EDM

Arm Type

Experimental

Arm Description

Endodontic file

Intervention Type

Device

Intervention Name(s)

TruNatomy Files

Intervention Description

Newly introduced endodontic file with high flexibility.

Intervention Type

Device

Intervention Name(s)

HyFlex EDM Files

Intervention Description

Endodontic files

Primary Outcome Measure Information:

Title

Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain

Description

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.

Time Frame

Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.

Secondary Outcome Measure Information:

Title

Number of analgesics taken by the patient after endodontic treatment

Description

Counting Number of analgesics taken by the patient after endodontic treatment

Time Frame

up to 7 days post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 25 - 45 years old. Males or Females. Mandibular molar teeth with: No pain. No response to pulp testing. Radiographic appearance with or without a periapical radiolucency. Exclusion Criteria: Patients with pre-operative pain. Patients having significant systemic disorders. Patients who are allergic to non-steroidal anti-inflammatory drugs. Patients with two or more adjacent teeth requiring root canal therapy. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nora El Khater, B.D.S

Phone

02-01063918844

nora.khater@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Angie Ghoneim, PHD

angie.ghoneim@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angie Ghoneim, PHD

Organizational Affiliation

Cairo University

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

11307203

Citation

Thompson SA. An overview of nickel-titanium alloys used in dentistry. Int Endod J. 2000 Jul;33(4):297-310. doi: 10.1046/j.1365-2591.2000.00339.x.

Results Reference

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PubMed Identifier

23402273

Citation

Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.

Results Reference

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PubMed Identifier

3482231

Citation

Ruiz-Hubard EE, Gutmann JL, Wagner MJ. A quantitative assessment of canal debris forced periapically during root canal instrumentation using two different techniques. J Endod. 1987 Dec;13(12):554-8. doi: 10.1016/S0099-2399(87)80004-3. No abstract available.

Results Reference

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Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

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