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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Temporomandibular Joint Internal Derangement (ADWR)
• Intervention / Treatment: Drug: sodium valproate; Procedure: TMJ Arthrocentesis

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31773
      • Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IV Sodium Valproate + TMJ Arthrocentesis; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity measured by Visual Analogue Scale (VAS) Score	Patients self-reported pain levels on a scale from 0 (no pain) to 10 (worst imaginable pain).	Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximal Mouth Opening	Measured as the distance (digital caliper) between the incisal edges of the upper and lower central incisors during maximum comfortable opening.	Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.
Presence of Temporomandibular Joint Clicking	Clinical evaluation of the presence or absence of clicking sounds during jaw movement.	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	Using MRI to assess the resolution of joint effusion and the stability of the disc position following treatment.	6 months and 1 year post-operatively.

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Chair: Rafic Ramadan Beder, Ph.D., Professor of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University; Study Director: Ahmed A Mosleh, Ph.D., Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2024
• Primary Completion (Actual): May 6, 2025
• Study Completion (Estimated): May 6, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: inflammation; Anterior disc displacement with reduction; Temporomandibular joint disorder; synovial fluid; arthrocentesis; sodium valproate; interleukin-6
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Pathologic Processes; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Pathological Conditions, Signs and Symptoms; Inflammation; Temporomandibular Joint Disorders; Organic Chemicals; Investigative Techniques; Therapeutics; Fatty Acids; Lipids; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Acids, Acyclic; Carboxylic Acids; Pentanoic Acids; Valerates; Fatty Acids, Volatile; Valproic Acid; Arthrocentesis
• Other Study ID Numbers: OS-8-24-2245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient privacy and clinical confidentiality. Only de-identified aggregate data presented in the final thesis and any resulting publications will be made available to the scientific community.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No