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Clinical Trials in Egypt / NCT07487675
Active, not recruiting Phase 2

Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement

NCT07487675 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Phase 2
Started
2024-09-29
Last updated
2026-03-23

Condition(s) studied

Temporomandibular Joint Internal Derangement (ADWR)

Investigational drug(s) / intervention(s)

sodium valproate →TMJ Arthrocentesis

sodium valproate: Intravenous (IV) administration of sodium valproate. This is used as an adjunctive systemic therapy to modulate the inflammatory cascade (specifically targeting IL-6 levels) in the temporomandibular joint anterior disc with reduction (ADDWR)

TMJ Arthrocentesis: Conventional double-puncture arthrocentesis technique performed under local anesthesia. The superior joint space is lavage with 100 ml of Ringer's lactate solution to remove inflammatory mediators and release the articular disc.

Study 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.

Eligibility

Sex
FEMALE
Min age
17 Years
Max age
35 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • level of Interleukin-6 (IL-6) in Synovial Fluid — Baseline (immediately pre-operative) and Post-operative (immediately followed by conventional double-puncture arthrocentesis with 100 ml Ringer's lactate lavage.
    Evaluation of the anti-inflammatory effect of systemic sodium valproate by measuring the changes in IL-6 levels. Synovial fluid samples were analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique.

Trial sites (1)

FacilityCityRegionStatus
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University Tanta Gharbia Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07487675 on ClinicalTrials.gov ↗ ← All trials in Egypt