A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement

NCT ID: NCT06013059

Last Updated: 2023-10-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-07-30

Brief Summary

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The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.

Detailed Description

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Conditions

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TMJ Disc Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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level (I) arthroscopy (Lysis and lavage)

Group Type ACTIVE_COMPARATOR

three levels of TMJ arthroscopy

Intervention Type PROCEDURE

Group I: 10 patients will be treated with Lysis and lavage

level (II) arthroscopy (operative arthroscopy)

Group Type ACTIVE_COMPARATOR

three levels of TMJ arthroscopy

Intervention Type PROCEDURE

Group II: 10 patients will be treated with operative arthroscopy

level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)

Group Type ACTIVE_COMPARATOR

three levels of TMJ arthroscopy

Intervention Type PROCEDURE

Group III: 10 patients will be treated with operative arthroscopy + discopexy

Interventions

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three levels of TMJ arthroscopy

Group I: 10 patients will be treated with Lysis and lavage

Intervention Type PROCEDURE

three levels of TMJ arthroscopy

Group II: 10 patients will be treated with operative arthroscopy

Intervention Type PROCEDURE

three levels of TMJ arthroscopy

Group III: 10 patients will be treated with operative arthroscopy + discopexy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with TMJ internal derangement Wilkes III

Exclusion Criteria

1. Medically unfit patients.
2. Patients with TMDs secondary to malocclusion.
3. Psychological instability.
4. Patients operated before for other TMJ problems.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hamza Fayad

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Fayad, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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001056 - IORG 0008839

Identifier Type: -

Identifier Source: org_study_id

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