Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

NCT ID: NCT05289973

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-02-01

Brief Summary

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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

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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.

Conditions

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Endodontically Treated Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients having mandibular molars with necrotic pulp
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TruNatomy Files

Newly introduced endodontic file

Group Type EXPERIMENTAL

TruNatomy Files

Intervention Type DEVICE

Newly introduced endodontic file with high flexibility.

Hyflex EDM

Endodontic file

Group Type EXPERIMENTAL

HyFlex EDM Files

Intervention Type DEVICE

Endodontic files

Interventions

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TruNatomy Files

Newly introduced endodontic file with high flexibility.

Intervention Type DEVICE

HyFlex EDM Files

Endodontic files

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nora El-Sayed Khater

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angie Ghoneim, PHD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Nora El Khater, B.D.S

Role: CONTACT

02-01063918844

Angie Ghoneim, PHD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 11307203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23402273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3482231 (View on PubMed)

Other Identifiers

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TRN in postoperative pain

Identifier Type: -

Identifier Source: org_study_id

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