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Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients

2026年8月3日 更新者：Nikolaos Christidis、Karolinska Institutet

Platelet-Rich Plasma (PRP) Injections as Treatment for Myogenous Temporomandibular Disorders: A Randomized Clinical Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 瑞典
    • Stockholm County
      • Huddinge、Stockholm County、瑞典、17177
        • Karolinska Institutet - Department of Dental Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
程序：Platelet rich plasma (PRP)

PRP Injection (Experimental)

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.
安慰剂比较：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
药品：Saline (0.9% NaCl)
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 proce

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Pain Intensity (CPI 0-100)
大体时间：Baseline, 1 month, 3 months
Change in self-reported pain intensity , measured using a 0-100 Characteristic Pain Intensity (CPI). The assessment will be perform at baseline and at each follow-up.
Baseline, 1 month, 3 months

次要结果测量

结果测量
措施说明
大体时间
Change in Maximum Mouth Opening (MMO)
大体时间：Baseline, 1 month, 3 months
Change in maximum unassisted mouth opening in millimeters, measured using a standardized ruler. Higher values indicate improved mandibular mobility
Baseline, 1 month, 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Karolinska Institutet

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月4日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年12月20日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-01518-01
  • Karolinska Institutet (其他标识符：Karolinska Institutet)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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