NCT07487675

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

Evaluation The Effects Of Intravenous Sodium Valproate On The Interleukin-6 Profile In Patients With The Temporomandibular Joint Anterior Disc Displacement With Reduction

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 17 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective clinical study evaluates the anti-inflammatory efficacy and clinical outcomes of intravenous (IV) sodium valproate administration combined with temporomandibular joint (TMJ) arthrocentesis. The study population consisted of 10 adult female patients (ages 17-35) diagnosed with anterior disc displacement with reduction (ADDR) who were non-responsive to conservative management for at least 3 months. Procedure Methodology: All participants received an intravenous injection of sodium valproate. Following the systemic administration, a conventional double-puncture arthrocentesis was performed under local anesthesia. The joint space was lavage with 100 ml of Ringer's lactate solution. Outcome Assessment: Biochemical Analysis: Synovial fluid samples were collected via the arthrocentesis needles both immediately before the lavage (baseline) and after the treatment intervention. These samples were analyzed using Enzyme-Linked Immunosorbent Assay (ELISA) to quantify changes in Interleukin-6 (IL-6) concentrations. Clinical Evaluation: Pain intensity was measured using a Visual Analogue Scale (VAS). Mechanical function was assessed by measuring Maximal Mouth Opening (MMO) and recording the presence of joint clicking. These parameters were tracked at standardized intervals: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year post-operatively. Radiographic Imaging: Magnetic Resonance Imaging (MRI) was conducted at Pre-operative and post-operative 3 month ,6 month and 1 year marks to objectively evaluate disc position and the presence or resolution of joint effusion. The study aims to provide clinical evidence of sodium valproate's role as an adjunctive therapy in modulating the inflammatory cascade associated with TMJ pathology.

Conditions

• Temporomandibular Joint Internal Derangement (ADWR)

Interventions

Type	Name	Description
DRUG	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)
PROCEDURE	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.

Timeline

• Start date: 2024-09-29
• Primary completion: 2025-05-06
• Completion: 2026-05-06
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Egypt