Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction

this study will be done to detect the best management of temporo-mandibular joint anterior disc displacement without reduction, for diagnosis, we use MRI on the TMJ to detect status of the disc and joint space, for management, we try to select best operation as discopexy, discectomy with or without replacement, and we follow up the patients and detect side effects and effect for each operation

Study Overview

• Status: Not yet recruiting
• Conditions: Temporomandibular Joint Disc Displacement, Without Reduction
• Intervention / Treatment: Procedure: discectomy of the TMJ disc; Procedure: TMJ discopexy

Detailed Description

Discopexy is a procedure in which the displaced disk is freed by the surgeon and lysing adhesions first. The success of the disc repositioning depends on the degree of deformity and the extent of degenerative changes at the time of the arthroplasty. Repositioning the disc restores the condylar movement that was previously blocked by the displaced disc, stabilizes the joint, and improves nutrition and lubrication of articular cartilage. In addition, the workload of the masticatory muscles is reduced when the obstructing disc is repositioned. TMJ disc repositioning surgery seems to improve pain, mouth opening, and patient quality of life

Temporomandibular Joint (TMJ) arthroscopy is one of the most advanced and a minimally invasive technique involving optical instrumentation and prescribed surgical armamentarium, used for the treatment of the TMJ disorders. It is one of the most popular and effective methods of diagnosing and treating TMJ disorders since TMJ disorders have become an increasingly widespread problem in our society. Also, it enables the surgeon to visualize the joint and, therefore, contributes to the diagnosis of the internal pathological condition of the joint and allows inspection of a surgically undisturbed joint both at rest and in function

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A ALI, lecturer; Phone Number: 01093459925; Email: mohamed.abdelaal@med.sohag.edu.eg
• Study Contact Backup: Name: Kamal M Hassanein, professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• This study will include patients diagnosed as anterior disc displacement without reduction based on clinical manifestations and MRI.

Exclusion Criteria:

• o Patients with severe osteoarthritic changes of the condyle and glenoid fossa.

  • Patients with bony ankylosis.
  • Patients with infection or tumors around joint area.
  • Patients with previous TMJ surgery.
  • Any patient with systemic inflammatory disease or myopathic disease affecting TMJ such as Rheumatoid Arthritis And Systemic Lupus Erythromatosis.
  • Patients unfit for intervention.
  • Patients who refused to share in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with TMJ anterior disc displacement; patients had clinically limited mouth opening and by MRI we found anterior disc displacement	Procedure: discectomy of the TMJ disc; removal of the TMJ disc; Procedure: TMJ discopexy; fixation of the TMJ disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain of the TMJ	degree of pain related to TMJ measured by Visual Analogue Scoring System from 0 to 10 where 0 means no pain and 10 means severe unbearable pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mouth openning	degree of mouth opening measured in centimeters measured by ruler	3 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Kamal M El- sharkawy, proffessor, Sohag Univesity Hospitals

Study record dates

Study Major Dates

• Study Start (Anticipated): August 13, 2023
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-22-6-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared with other researchers through NIH(national institute of health)

Drug and device information, study documents

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