Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if arthrocentesis works as well as botulinum toxin (Botox) injection to treat pain and jaw dysfunction in adults with temporomandibular joint (TMJ) disorders. The main questions it aims to answer are: * Does arthrocentesis reduce pain more, less, or the same as Botox injection? * Does arthrocentesis improve jaw opening and function more, less, or the same as Botox injection? * What side effects do participants have with each treatment? Researchers will compare arthrocentesis to Botox injection to see which treatment works better for reducing pain and improving jaw movement in patients with TMJ disorders. Participants will: * Be randomly assigned to receive either arthrocentesis (a joint-washing procedure) or a Botox injection into the jaw muscles * Visit the clinic at 1, 3, and 6 months after treatment for checkups and assessments - Rate their pain and have their jaw movement measured at each visit * Complete short questionnaires about their jaw function and quality of life

Вмешательства

• Процедура Arthrocentesis
  Temporomandibular joint (TMJ) arthrocentesis will be performed under local anesthesia using a standard two-needle technique. Two needles will be inserted into the superior joint space, and the joint will be irrigated with sterile isotonic solution (e.g., Ringer's lactate or normal saline, approximately 100-300 mL) to lavage inflammatory mediators and break minor intra-articular adhesions. The procedure will be performed as a single session by a trained oral and maxillofacial surgeon. Patients wi
• Препарат Botulinum Toxin-A
  Botulinum toxin type A (Botox) will be injected intramuscularly into the masseter and temporalis muscles bilaterally. Injection sites will be determined by palpation of muscle bulk and activity during voluntary contraction (patients will be asked to clench their teeth to identify the muscle borders and the point of maximal bulk/tenderness). The total dose will be 25-50 units per masseter muscle and 10-25 units per temporalis muscle, administered as a single session. The procedure will be perfo

Первичные конечные точки

• Change in Pain Intensity Measured by Visual Analog Scale (VAS) [Срок оценки: Baseline, 1 month, 3 months, and 6 months post-treatment]

Критерии участия

Критерии включения

• Clinically and radiographically confirmed temporomandibular joint (TMJ) disorder, diagnosed according to Wilkes staging or the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
• Age 18 years or older
• Symptom duration of at least 3 months
• Unresponsive to conservative therapy
• Willing and able to provide written informed consent

Критерии исключения

• Previous TMJ surgery
• Systemic rheumatic/inflammatory joint disease (e.g., rheumatoid arthritis, ankylosing spondylitis)
• Bony ankylosis of the TMJ
• Pregnancy
• Known allergy or contraindication to botulinum toxin
• Concurrent use of muscle relaxants, corticosteroids, or anticoagulant medication that may confound treatment effects
• Unwillingness or inability to attend scheduled follow-up visits

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07736521 · MBA-20-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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