Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
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: Liquid Phase Concentrated Growth Factor, Conventional arthrocentesis.
- Кому может быть актуально
- Состояния в реестре: Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint, Anterior Disc Displacement. Базовые параметры: 18 лет — 45 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Injection of Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Management of Temporomandibular Disc Displacement: A Randomized Controlled Clinical Trial
Обзор
This study aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential role of (LPCGF) as an alternative therapeutic choice for IDD.
Вмешательства
- Процедура Liquid Phase Concentrated Growth Factor
16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with injection of liquid phase concentrated growth factor - Процедура Conventional arthrocentesis
16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis
Первичные конечные точки
- Assess and comparing the pain of both groups [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- Assess and comparing the mouth opening of both groups [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
Вторичные конечные точки (5)
- Joint sounds [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- Mandibular deviation during mouth opening. [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- Lateral and protrusive movements [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention]
- tenderness on palpation [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- TMD symptoms [Срок оценки: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
Критерии участия
Критерии включения
- 1\. Adults aged 18-45 years. 2. Patients scored as (ASA I).9 3. Presence of complete or nearly complete set of natural dentition with Angle class I occlusion. 4. Diagnosed with unilateral involvement of disc displacement, according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).10 5. Symptoms include one or more of the following: pain, joint sounds, and limited mandibular movement (Maximum Mouth Opening< 40mm) 6. No prior surgical intervention for TMD. 7. Patient's willingness to participate and follow the study protocol.
Критерии исключения
- 1\. TMJ pathology related to mechanical deformities 2. Psychiatric problems or presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, autoimmune disorders, hematologic or neurologic disorders, inflammatory or connective tissue disorders as well as rheumatological or previous infectious diseases, head and neck cancer). 3. Patient unwilling or has contraindication to MRI 4. Previous injections or surgical interventions of the TMJ. 5. Concurrent use of anticoagulants or anti-inflammatory medications within the last 30 days. 6. Pregnant or breastfeeding women. 7. History of trauma or infection in the TMJ region. 8. Allergy to local anesthetics or other components used in the study. 9. Patients diagnosed with (Disc Displacement with reduction with no pain or limited mandibular movements).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Faculty of Dentistry- Horus University in Egypt — Damietta
Идентификаторы
NCT: NCT07075276 · CGF for management of TMDs