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

A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: TMJ Disc Disorder
• Intervention / Treatment: Procedure: three levels of TMJ arthroscopy; Procedure: three levels of TMJ arthroscopy; Procedure: three levels of TMJ arthroscopy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: level (I) arthroscopy (Lysis and lavage)	Procedure: three levels of TMJ arthroscopy; Group I: 10 patients will be treated with Lysis and lavage; Procedure: three levels of TMJ arthroscopy; Group II: 10 patients will be treated with operative arthroscopy; Procedure: three levels of TMJ arthroscopy; Group III: 10 patients will be treated with operative arthroscopy + discopexy
Active Comparator: level (II) arthroscopy (operative arthroscopy)	Procedure: three levels of TMJ arthroscopy; Group I: 10 patients will be treated with Lysis and lavage; Procedure: three levels of TMJ arthroscopy; Group II: 10 patients will be treated with operative arthroscopy; Procedure: three levels of TMJ arthroscopy; Group III: 10 patients will be treated with operative arthroscopy + discopexy
Active Comparator: level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)	Procedure: three levels of TMJ arthroscopy; Group I: 10 patients will be treated with Lysis and lavage; Procedure: three levels of TMJ arthroscopy; Group II: 10 patients will be treated with operative arthroscopy; Procedure: three levels of TMJ arthroscopy; Group III: 10 patients will be treated with operative arthroscopy + discopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mouth opening measurement	measuring the maximal interincisal opening (MIO)	1, 3 and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mohamed Fayad, MD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 001056 - IORG 0008839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No