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Not yet recruiting NCT07606378

Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients

No phase Interventional Myogenic Temporomandibular Joint Disorders Myofacial Pain Masseter Muscle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline (0.9% NaCl), Platelet rich plasma (PRP).
Who it may be relevant to
Registry conditions: Myogenic Temporomandibular Joint Disorders, Myofacial Pain, Masseter Muscle. Basic parameters: 20 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug 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
  • Procedure 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 u

Primary outcome measures

  • Change in Pain Intensity (CPI 0-100) [Time frame: Baseline, 1 month, 3 months]
Secondary outcome measures (1)
  • Change in Maximum Mouth Opening (MMO) [Time frame: Baseline, 1 month, 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Karolinska Institutet - Department of Dental Medicine — Huddinge

Identifiers

NCT: NCT07606378 · 2026-01518-01 · Karolinska Institutet

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗