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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nikolaos Christidis Professor, PhD
- Número de teléfono: +4685288124
- Correo electrónico: nikolaos.christidis@ki.se
Ubicaciones de estudio
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Stockholm County
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Huddinge, Stockholm County, Suecia, 17177
- Karolinska Institutet - Department of Dental Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Pain Intensity (CPI 0-100)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Maximum Mouth Opening (MMO)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-01518-01
- Karolinska Institutet (Otro identificador: Karolinska Institutet)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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