Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Disp… (NCT07487675) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement
Egypt10 participantsStarted 2024-09-29
Plain-language summary
This study aims to evaluate if adding the medication Sodium Valproate to a standard jaw procedure (arthrocentesis) can help reduce inflammation and improve healing in patients with certain jaw joint problems.
The jaw joint, known as the temporomandibular joint (TMJ), can sometimes become painful or "click" due to a condition called anterior disc displacement. A common treatment is arthrocentesis, which involves washing out the joint. In this study, researchers are testing whether injecting Sodium Valproate during this procedure reduces the levels of Interleukin-6 (IL-6), a specific protein that causes inflammation, more effectively than the procedure alone.
Participants will have their joint fluid tested before and after the treatment to see if the levels of this inflammatory protein have decreased.
Who can participate
Age range
17 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients between the ages of 17 and 35 years.
* Clinical and radiographic diagnosis (via MRI) of TMJ anterior disc displacement with reduction (ADDWR).
* Patients who failed to respond to conservative treatment (e.g., medication, splint therapy, or physical therapy) for more than three months.
* Presence of clinical symptoms including joint pain, clicking sounds, or limited mouth opening.
Exclusion Criteria:
* History of previous TMJ surgery or arthrocentesis.
* Presence of systemic inflammatory diseases or metabolic bone diseases (e.g., rheumatoid arthritis).
* Evidence of bony changes in the TMJ (e.g., osteoarthritis or ankylosis).
* patients with history of systemic immune disease
* Patients with TMJ neoplastic changes.
* Patients with history of recent facial trauma
* Patients with high risk of hemorrhage
* Patients with prosthetic joint replacement
* Patients with allergic to any component of the injectable solution.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
level of Interleukin-6 (IL-6) in Synovial Fluid
Timeframe: Baseline (immediately pre-operative) and Post-operative (immediately followed by conventional double-puncture arthrocentesis with 100 ml Ringer's lactate lavage.