Arthroscope-Guided Intra-Articular Injection of Chitosan-Hyaluronate Gel Mixture Versus Hyaluronic Acid in the Treatment of TMJ Internal Derangement: A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study is designed to assess the impact of injecting sodium hyaluronic acid versus a chitosan-hyaluronate hybrid gel into the upper compartment of the temporomandibular joint (TMJ) as a treatment for anterior disc displacement without reduction. The study will include patients diagnosed with Stage III or IV TMJ internal derangement (anterior disc displacement without reduction), as classified by Wilkes, with diagnoses confirmed through clinical symptoms and MRI evaluations. Participants will be randomly divided into two groups, both undergoing TMJ arthroscopy. In the first group, 2 ml of chitosan-hyaluronic acid hybrid gel will be injected into the affected joints, whereas in the second group, 2 ml of hyaluronic acid (HA) will be administered. The study will compare and analyze outcomes in both groups, focusing on pain during TMJ function, clicking sounds, the extent of maximum mouth opening, and maximum lateral jaw movement.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 50
Healthy Volunteers: f
View:

• Patients were diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations.

• Age 25 - 50 years old.

Locations
Other Locations
Egypt
Suez University
RECRUITING
Suez
Contact Information
Primary
Nehal IA Shobair, PhD
nehal.shobair@miuegypt.edu.eg
00201063666985
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2024-07-01
Participants
Target number of participants: 20
Treatments
Active_comparator: Intra-Articular Injection of Hyaluronic Acid
Arthroscope-guided intra-articular injection of Hyaluronic Acid in patients with TMJ anterior disc displacement without reduction.
Active_comparator: Intra-Articular Injection of chitosan-hyaluronate gel mixture
Arthroscope-guided intra-articular injection of chitosan-hyaluronate gel mixture in patients with TMJ anterior disc displacement without reduction
Related Therapeutic Areas
Sponsors
Collaborators: Misr International University, University of Nizwa
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov

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