Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mandibular Movements: measured in millimeters using a ruler or digital caliper.
研究概览
简要总结
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
详细描述
The internal derangement (ID) of the TMJ is an improper functional and positional connection between the articular components of the joint. It has been estimated that 80% of TMD patients have ID, which is typically classified into two classes: disc displacement with reduction and disc displacement without reduction.
The ID of the TMJ was often accompanied by the increased expression of COX-2 in both synovium and synovial fluid. This allows the accumulation of prostaglandins in synovial fluid, accompanied by peripheral Vaso permeability, that may lead to swollen synovium. Patients may become suffering from limited jaw motion and associated pain around the TMJ in this stage.
Arthrocentesis reduces the pain through removing the adherences, eliminates the negative pressure in the joint, washes the inflammatory mediators, distends the joint space, recovering the space of the joint disc and fossa, changes the viscosity of the synovial liquid.
Reducing discomfort, restoring normal mandibular motions, and enhancing patients' quality of life are all necessary components of effective treatment for arthrogenous TMDs.
Treatment of TMJ-ID with arthrocentesis, either alone or in conjunction with intraarticular injections, is quite successful. It enhances jaw motions, promotes mouth opening, and lessens discomfort. For intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids and non-steroidal anti-inflammatory medications (NSAIDS) are used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from 18 to 40 years old.
- •patients diagnosed with ID of TMJ, suffering from limited mandibular movements, joint pain and clicking.
- •Patients who are free from any systemic disease and controlled systemic disease (ASA I) (ASA II).
- •Patients willing to comply with the follow-up schedule and treatment protocol.
- •both genders are included
排除标准
- •Patients with systemic diseases (ASA III, IV, V).
- •Patients who have myofascial pain dysfunction syndrome only.
- •Patients who have previous surgery in TMJ.
- •Patients who have previous arthrocentesis within 1 year.
- •Patients who received previous trauma to the joint.
- •Use of anticoagulants or immunosuppressive medications.
研究组 & 干预措施
patients with anterior disc displacement with reduction
10 cases with anterior disc displacement with reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).
干预措施: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis (Combination Product)
patients with anterior disc displacement without reduction
10 cases with anterior disc displacement without reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).
干预措施: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis (Combination Product)
结局指标
主要结局
Mandibular Movements: measured in millimeters using a ruler or digital caliper.
时间窗: immediately, one, three and six months postoperatively
Mandibular Movements: Including maximum mouth opening (MMO), right and left lateral movements, and protrusive movement, measured in millimeters using a ruler or digital caliper.
Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.
时间窗: immediately, one, three, six months postoperatively
Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.
pain assessed by visual analogue scale
时间窗: preoperatively, one, three and six months postoperatively
Pain: Assessed using a Visual Analogue Scale ranging from 0 to 10 over the TMJ area \[ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain\].
次要结局
未报告次要终点