Comparative Study Between Level I and Level II Temporomandibular Joint Arthroscopy in Wilkes Stage III Patients

NCT ID: NCT06661096

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-13
• Study Completion Date: 2025-10-15

Brief Summary

Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery

Detailed Description

Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMJ dysfunction

TMJ arthroscopy

Group Type: EXPERIMENTAL

TMJ arthroscopy

Intervention Type: PROCEDURE

level I and level II TMJ arthroscopy

Interventions

TMJ arthroscopy

level I and level II TMJ arthroscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Wilkes stage III patients

Exclusion Criteria

• previous TMJ surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamed Gamal Thabet

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Gamal Thabet

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohamed Gamal Thabet, MD

Role: PRINCIPAL_INVESTIGATOR

MGThabet

Locations

Assiut university

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

TMJ arthroscopy

Identifier Type: -

Identifier Source: org_study_id