A Comparative Study Between TMJ Discopexy to External Ear Cartilage Versus to Temporal Fascia

February 24, 2025 updated by: Alshaimaa Ahmed shabaan, Fayoum University
Discopexy is a surgical procedure aimed at stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD). The TMJ is a complex joint responsible for jaw movement, and its proper function relies on the alignment and stability of the articular disc, a fibrocartilaginous structure that cushions the joint. In cases of disc displacement or dysfunction, patients may experience pain, clicking, limited jaw movement, and other symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Discopexy involves repositioning and securing the displaced disc to its anatomical position, often using sutures or anchors, to restore normal joint mechanics and alleviate symptoms. This procedure is typically considered when conservative treatments, such as physical therapy or splints, have failed to provide relief. Discopexy aims to improve joint function, reduce pain, and prevent further degenerative changes in the TMJ. The aim of the present study is to compare between new surgical techniques of discopexy of TMJ disc either to external ear cartilage or to temporal fascia.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt, 63514
        • Faculty of Dentistry- Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with primary TMD with complete anterior disc displacement without reduction with no or minimal osteoarthritic changes

Exclusion Criteria:

  • osteoarthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: discopexy of Temporo-mandibular joint (TMJ) disc to external ear cart
30 patients underwent discopexy of Temporo-mandibular joint (TMJ) disc to external ear cartilage
Procedure: Discopexy to external ear cartilage
stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to external ear cartilage
Active Comparator: discopexy of TMJ disc to temporal fascia.
Patients underwent discopexy of TMJ disc to temporal fascia.
Procedure: Discopexy to temporal fascia
stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to temporal fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS)
Time Frame: baseline, 1 month, 3 months, 6 months
The Visual Analog Scale (VAS) It consists of a straight line, typically 10 centimeters (100 mm) in length, with one end labeled "No Pain" and the other end labeled "Worst Pain Imaginable."
baseline, 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disc position
Time Frame: baseline, 1 month, 3 months, 6 months
assess the position of the articular disc in the TMJ either Normal, anterior displacement (with or without reduction), posterior displacement, or lateral displacement.
baseline, 1 month, 3 months, 6 months
Maximum Mouth opening
Time Frame: baseline, 1 month, 3 months, 6 months
used to assess the functional capacity of the temporomandibular joint (TMJ) and the surrounding musculoskeletal structures.
baseline, 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Collaborators

Sohag University

Investigators

  • Principal Investigator: Alshaimaa shabaan, PhD, Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

July 19, 2024

Study Completion (Actual)

January 22, 2025

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TMJ discopexy

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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