Temporomandibular Joint Internal Derangement (ADWR)
Conditions
Keywords
Temporomandibular joint disorder, sodium valproate, interleukin-6, arthrocentesis, Anterior disc displacement with reduction, synovial fluid, inflammation
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.
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.
Interventions
DRUGsodium 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)
PROCEDURETMJ 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.
Sponsors
Tanta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Patients self-reported pain levels on a scale from 0 (no pain) to 10 (worst imaginable pain). |
Countries
Egypt
Contacts
STUDY_CHAIRRafic Ramadan Beder, Ph.D.
Professor of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University
STUDY_DIRECTORAhmed A Mosleh, Ph.D.
Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University
Outcome results
None listed