The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06013059
Recruitment Status : Completed
First Posted : August 28, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Hamza Fayad, Alexandria University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
TMJ Disc Disorder Procedure: three levels of TMJ arthroscopy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : December 1, 2022
Actual Study Completion Date : July 30, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Active Comparator: level (II) arthroscopy (operative arthroscopy) Procedure: three levels of TMJ arthroscopy
Group II: 10 patients will be treated with operative arthroscopy
Active Comparator: level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation) Procedure: three levels of TMJ arthroscopy
Group III: 10 patients will be treated with operative arthroscopy + discopexy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mouth opening measurement [ Time Frame: 1, 3 and 6 months postoperatively ]
    measuring the maximal interincisal opening (MIO)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06013059


Locations
Layout table for location information
Egypt
Alexandria University
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed Fayad, MD Alexandria University
  Study Documents (Full-Text)

Documents provided by Mohamed Hamza Fayad, Alexandria University:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] February 2, 2022

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mohamed Hamza Fayad, Assistant lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT06013059    
Other Study ID Numbers: 001056 - IORG 0008839
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No