Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorKarolinska Institutet
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
active infection or inflammation at the injection site
systemic infection
platelet or coagulation disorders
severe anemia;
Trial design
Design model
Parallel
Treatments tested in this trial
Saline (0.9% NaCl)
DrugParticipants 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/SurgeryPRP 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PRP InjectionExperimental treatment 1 intervention
Group B: Saline InjectionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity (CPI 0-100)
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.
Time frame
Baseline, 1 month, 3 monthsSecondary outcomes
1
Change in Maximum Mouth Opening (MMO)
Change in maximum unassisted mouth opening in millimeters, measured using a standardized ruler. Higher values indicate improved mandibular mobility
Time frame
Baseline, 1 month, 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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