Masseter Muscle, Myofacial Pain, Myogenic Temporomandibular Joint Disorders
Conditions
Keywords
Temporomandibuar disorders, Myogenous TMD, Myofascial Pain, Orofacial Pain, Masseter Muscle, Platelet-Rich Plasma, PRP Injection, Regenerative Therapy, Intramuscular Injection, Pain Modulation
Brief summary
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
DRUGSaline (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
PROCEDUREPlatelet 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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (CPI 0-100) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Mouth Opening (MMO) | Baseline, 1 month, 3 months | Change in maximum unassisted mouth opening in millimeters, measured using a standardized ruler. Higher values indicate improved mandibular mobility |
Countries
Sweden
Contacts
CONTACTNikolaos Christidis Professor, PhD
Outcome results
None listed