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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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. |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University | Tanta | Gharbia Governorate | 31773 | Egypt |
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| Label | URL |
|---|---|
| Official website of the Faculty of Dentistry, Tanta University. | View source |
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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.
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D000069237 | Arthrocentesis |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| 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. |
|
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. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |