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NCT Number: NCT07606378

Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients

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.

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Key information

Conditions

Myogenic Temporomandibular Joint Disorders Facial Pain Masseter Muscle Myofacial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet - Department of Dental Medicine

Huddinge, Stockholm County, 17177, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • for the experimental part of the project are: women 20 to 50 years with a confirmed diagnosis of myogenous TMD according to the DC/TMD (21). 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 disease, uncontrolled diabetes, or active malignancy. Pregnancy or breastfeeding will also be exclusion criteria. Patients using anticoagulant or antiplatelet medication that cannot be temporarily discontinued, or receiving chronic corticosteroid or immunosuppressive therapy, will be excluded. Additional exclusion criteria include predominantly arthralgia temporomandibular disorders, previous temporomandibular joint surgery, or a history of significant trauma to the face, head, or neck, including orthognathic surgery. Patients will also be excluded if they present widespread pain conditions such as fibromyalgia, 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. Patients unable to provide informed consent or complete study questionnaires will be excluded.

Treatment and study plan

Saline (0.9% NaCl)

Drug

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

Platelet Rich Plasma (PRP)

Procedure

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.

Primary outcomes

  1. Change in Pain Intensity (CPI 0-100)

    Time frame: 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.

Secondary outcomes

  1. Change in Maximum Mouth Opening (MMO)

    Time frame: Baseline, 1 month, 3 months

    Change in maximum unassisted mouth opening in millimeters, measured using a standardized ruler. Higher values indicate improved mandibular mobility

Study contacts

Contact information is provided by the study sponsor or research team.

Nikolaos Christidis Professor, PhD

CONTACT

[email protected]

+4685288124

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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