Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients
Platelet-Rich Plasma (PRP) Injections as Treatment for Myogenous Temporomandibular Disorders: A Randomized Clinical 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nikolaos Christidis Professor, PhD
- Telefoonnummer: +4685288124
- E-mail: nikolaos.christidis@ki.se
Studie Locaties
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Stockholm County
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Huddinge, Stockholm County, Zweden, 17177
- Karolinska Institutet - Department of Dental Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: PRP Injection
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. |
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. |
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Placebo-vergelijker: Saline Injection
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 |
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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Pain Intensity (CPI 0-100)
Tijdsspanne: Baseline, 1 month, 3 months
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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.
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Baseline, 1 month, 3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Maximum Mouth Opening (MMO)
Tijdsspanne: Baseline, 1 month, 3 months
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Change in maximum unassisted mouth opening in millimeters, measured using a standardized ruler.
Higher values indicate improved mandibular mobility
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Baseline, 1 month, 3 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-01518-01
- Karolinska Institutet (Andere identificatie: Karolinska Institutet)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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