Comparing two gel treatments for TMJ disc disorders
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
PHASE4 · Ain Shams University · NCT06426199
This study is testing whether a new gel treatment works better than a standard gel for helping people with TMJ disc problems feel less pain and move their jaw more easily.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Suez) |
| Trial ID | NCT06426199 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of injecting a chitosan-hyaluronate hybrid gel versus hyaluronic acid into the temporomandibular joint (TMJ) to treat anterior disc displacement without reduction. Patients diagnosed with Stage III or IV TMJ internal derangement will be randomly assigned to receive one of the two treatments during TMJ arthroscopy. The study will assess outcomes such as pain during TMJ function, clicking sounds, and the range of jaw movement before and after treatment. A total of 20 participants will be included, with careful selection based on clinical and MRI evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 50 diagnosed with TMJ internal derangement classified as Stage III or IV.
Not a fit: Patients with hematological or neurological diseases, inflammatory conditions, or prior TMJ treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved jaw function for patients with TMJ disorders.
How similar studies have performed: Previous studies have shown promise in using hyaluronic acid for TMJ disorders, but the combination with chitosan is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Age 25 - 50 years old. Exclusion Criteria: 1. Hematological or neurological diseases. 2. Inflammation or connective tissue diseases. 3. Head and neck malignancies. 4. History of treatment of TMJ disease or history of craniofacial surgery not related to ID treatment. 5. Insufficient clinical and MRI data.
Where this trial is running
Suez
- Suez University — Suez, Egypt (RECRUITING)
Study contacts
- Study coordinator: Nehal IA Shobair, PhD
- Email: nehal.shobair@miuegypt.edu.eg
- Phone: 00201063666985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TMJ Disc Disorder, TMD, Hyaluronic acid, Chitosan, Arthroscopy, Intra Articular Injection, TMJ