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临床试验/CTRI/2025/07/091454
CTRI/2025/07/091454招募中不适用

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

Manav Rachna Dental College1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8月1日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kumar Rakshak Anand

Manav Rachna Dental College

研究点 (1)

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