Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients

NCT07606378 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-01518-01Karolinska Institutet
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myogenic Temporomandibular Joint Disorders; Myofacial Pain; Masseter Muscle

Keywords

Temporomandibuar disorders; Myogenous TMD; Myofascial Pain; Orofacial Pain; Masseter Muscle; Platelet-Rich Plasma; PRP Injection; Regenerative Therapy; Intramuscular Injection; Pain Modulation

Outcome Measures

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.

  Baseline, 1 month, 3 months

Secondary Outcomes (1)

• Change in Maximum Mouth Opening (MMO)

  Baseline, 1 month, 3 months

Study Arms (2)

PRP Injection

EXPERIMENTAL

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.

Procedure: Platelet rich plasma (PRP)

Saline Injection

PLACEBO COMPARATOR

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

Drug: Saline (0.9% NaCl)

Interventions

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

Saline Injection

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.

PRP Injection

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet - Department of Dental Medicine

Huddinge, Stockholm County, 17177, Sweden

Location

MeSH Terms

Conditions

Facial Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Nikolaos Christidis Professor, PhD

CONTACT

+4685288124; nikolaos.christidis@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: August 4, 2026
• Primary Completion: August 30, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-08

Locations

SE (1)