Меню
Набор скоро начнётся NCT07606378

Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients

Без фазы С лечением Myogenic Temporomandibular Joint Disorders Myofacial Pain Masseter Muscle

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Saline (0.9% NaCl), Platelet rich plasma (PRP).
Кому может быть актуально
Состояния в реестре: Myogenic Temporomandibular Joint Disorders, Myofacial Pain, Masseter Muscle. Базовые параметры: 20 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Platelet-Rich Plasma (PRP) Injections as Treatment for Myogenous Temporomandibular Disorders: A Randomized Clinical Trial

Обзор

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.

Вмешательства

  • Препарат Saline (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
  • Процедура Platelet 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 u

Первичные конечные точки

  • Change in Pain Intensity (CPI 0-100) [Срок оценки: Baseline, 1 month, 3 months]
Вторичные конечные точки (1)
  • Change in Maximum Mouth Opening (MMO) [Срок оценки: Baseline, 1 month, 3 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Karolinska Institutet - Department of Dental Medicine — Huddinge

Идентификаторы

NCT: NCT07606378 · 2026-01518-01 · Karolinska Institutet

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗