Evaluation of efficacy of platelet rich plasma (PRP) and sonicated platelet lysate (SPL) in the management of temporomandibular joint disorders – a randomized controlled clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 3. Clicking
研究概览
简要总结
Temporomandibular Joint Disorders (TMD) are musculoskeletal conditions causing pain, joint dysfunction, and impaired jaw movement. Traditional treatments offer only temporary relief and lack regenerative potential. This randomized controlled clinical trial aims to compare the efficacy of Platelet-Rich Plasma (PRP) and Sonicated Platelet Lysate (SPL) in improving pain, jaw function, and joint structure in patients with TMD.
A total of 34 patients not responding to conservative therapy will be randomly assigned to receive either PRP or SPL intra-articular injection. The primary outcomes include pain relief (Visual Analogue Scale) and functional improvement (mouth opening, jaw deviation, joint sounds). Secondary outcomes include MRI-based morphological changes and quality of life assessments.
Clinical assessment will be done preoperatively and at 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively. Radiographic assessment using MRI will be conducted preoperatively and at 12 months. Quality of life will be assessed at 6 and 12 months post-treatment. Both participants and outcome assessors will be blinded to the group assignments to ensure objective evaluation.
The study aims to identify the more effective biologic therapy and promote a minimally invasive, evidence-based approach for TMD management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients not responding to conservative treatment
- •Patients who comes under stage 2 and stage 3 of Wilke’s classification of internal derangement or having TMJ osteoarthritis.
排除标准
- •Age group less than 18
- •Prior TMJ surgery
- •Relief with conservative treatment
- •Systemic disorder and immunocompromised patients
- •Patients under antiplatelets, anticoagulants, steroids or Immunosuppressant medication
- •Patients not willing to participate in the study.
结局指标
主要结局
3. Clicking
时间窗: preoperatively, 7days, 1month, 3 months, 6 months and 12 months postoperatively
4. Jaw deviation
时间窗: preoperatively, 7days, 1month, 3 months, 6 months and 12 months postoperatively
FUNCTIONAL (clinical)
时间窗: preoperatively, 7days, 1month, 3 months, 6 months and 12 months postoperatively
1. Maximum mouth opening
时间窗: preoperatively, 7days, 1month, 3 months, 6 months and 12 months postoperatively
2. Tenderness on palpation
时间窗: preoperatively, 7days, 1month, 3 months, 6 months and 12 months postoperatively
次要结局
- MORPHOLOGICAL (radiographic)(Joint morphology using MRI)
- QUALITY OF LIFE(6 month and 12 months postoperatively)
研究者
Dr Kumar Rakshak Anand
Manav Rachna Dental College
