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

NCT07487675 | Active Not Recruiting Phase 2

• 1 other identifier: OS-8-24-2245
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Joint Internal Derangement (ADWR)

Keywords

Temporomandibular joint disorder; sodium valproate; interleukin-6; arthrocentesis; Anterior disc displacement with reduction; synovial fluid; inflammation

Outcome Measures

Primary Outcomes (1)

• level of Interleukin-6 (IL-6) in Synovial Fluid

  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.

  Baseline (immediately pre-operative) and Post-operative (immediately followed by conventional double-puncture arthrocentesis with 100 ml Ringer's lactate lavage.

Secondary Outcomes (1)

• Pain Intensity measured by Visual Analogue Scale (VAS) Score

  Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.

Other Outcomes (3)

• Change in Maximal Mouth Opening

  Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.

• Presence of Temporomandibular Joint Clicking

  Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.

• Radiographic Evaluation of Joint Effusion and Disc Position

  6 months and 1 year post-operatively.

Study Arms (1)

IV Sodium Valproate + TMJ Arthrocentesis

EXPERIMENTAL

A single experimental group of 10 female patients (ages 17-35) diagnosed with TMJ internal derangement (ADDR). Each participant received a systemic intravenous dose of sodium valproate followed by conventional double-puncture arthrocentesis of the superior joint space with 100 ml Ringer's lactate lavage.

Drug: sodium valproate; Procedure: TMJ Arthrocentesis

Interventions

sodium valproate DRUG

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)

IV Sodium Valproate + TMJ Arthrocentesis

TMJ Arthrocentesis PROCEDURE

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.

IV Sodium Valproate + TMJ Arthrocentesis

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31773, Egypt

Location

Related Links

• Official website of the Faculty of Dentistry, Tanta University.

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Inflammation

Interventions

Valproic Acid; Arthrocentesis

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rafic Ramadan Beder, Ph.D.

  Professor of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University

  STUDY CHAIR

• Ahmed A Mosleh, Ph.D.

  Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Candidate, Faculty of Dentistry, Tanta University

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: September 29, 2024
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)