Evaluation The Effects Of Intravenous Sodium Valproate On The Interleukin-6 Profile In Patients With The Temporomandibular Joint Anterior Disc Displacement With Reduction
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- level of Interleukin-6 (IL-6) in Synovial Fluid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
level of Interleukin-6 (IL-6) in Synovial Fluid
时间窗: 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.
次要结局
- 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.)
研究者
Roaa Hassan Jafar Al. Hassan
Master's Candidate, Faculty of Dentistry, Tanta University
Tanta University