Platelet-Rich Plasma (PRP) Injections as Treatment for Myogenous Temporomandibular Disorders: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate whether intramuscular injections of platelet-rich plasma (PRP) are more effective than isotonic saline in reducing pain and improving jaw function in individuals diagnosed with myogenous temporomandibular disorders (TMD). Myogenous TMD is a common source of orofacial muscle pain and functional limitation, and although conservative treatments help many patients, a significant proportion continue to experience persistent symptoms that affect daily life and quality of function.
PRP is an autologous, minimally invasive biologic concentrate enriched with platelets and bioactive molecules that may promote tissue repair and modulate inflammation, making it a promising option for managing muscle-related pain conditions. However, evidence from well-controlled randomized clinical trials in myogenous TMD remains limited.
In this double-blind, randomized controlled clinical trial, participants will receive two intramuscular injections-either PRP or saline-administered one month apart. Follow-up assessments will occur at 1, 3, and 6 months using standardized and validated measures of pain intensity, pain sensitivity, mandibular function, and psychosocial factors.
The results of this study may help determine the clinical value of PRP for myogenous TMD and contribute to future standardization of regenerative treatment protocols in orofacial pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 20 to 50 years with a confirmed diagnosis of myogenous TMD according to the DC/TMD
- •participants must have pain in the masticatory muscles
- •pain duration must be at least 3 months
- •participants must report current pain at the day of inclusion with a minimum score of 4 on the numeric rating scale (NRS 0 to 10)
排除标准
- •active infection or inflammation at the injection site
- •systemic infection
- •platelet or coagulation disorders
- •severe anemia;
- •autoimmune or inflammatory rheumatic disease;
- •chronic liver diseases;
- •uncontrolled diabetes;
- •pregnancy or breastfeeding will also be exclusion criteria
- •individuals using anticoagulant or antiplatelet medication that cannot be temporarily discontinued or receiving chronic corticosteroid or immunosuppressive therapy
- •predominantly arthralgia temporomandibular disorders
- •previous temporomandibular joint surgery, or a history of significant trauma to the face, head, or neck, including orthognathic surgery
- •individuals with fibromyalgia
- •individuals with neuromuscular disorders such as craniomandibular dystonia or myasthenia gravis, diagnosed or severe psychiatric disease such as schizophrenia or bipolar disorder, neuropathic pain, or pain of dental origin
- •individuals unable to provide informed consent or complete study questionnaires will be excluded
研究组 & 干预措施
Saline Injection
Saline Injection (Placebo Comparator)
Arm Description:
Participants in this arm will receive intramuscular injections of isotonic 0.9% saline into the masseter muscles. The injection technique, number of points (three per masseter), volume per point (0.3 mL), and needle type are identical to the PRP arm to maintain procedural consistency. A second saline injection will be administered at the 1-month follow-up visit. All proc
干预措施: Saline (0.9% NaCl) (Drug)
PRP Injection
PRP Injection (Experimental)
Arm Description:
Participants in this arm will receive intramuscular injections of platelet-rich plasma (PRP) into the masseter muscles. PRP is prepared using a standardized two-step centrifugation protocol to obtain the platelet-rich fraction. Each session includes injections at three marked points per masseter muscle, with 0.3 mL injected per point (total 1.8 mL per session). A second PRP injection will be administered at the 1-month follow-up visit. All procedures are performed under double-blind conditions.
干预措施: Platelet rich plasma (PRP) (Procedure)
研究者
Nikolaos Christidis
Professor
Karolinska Institutet