Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement

Обзор

This randomized controlled clinical study is designed to evaluate the clinical effectiveness of combining temporomandibular joint (TMJ) arthrocentesis with a single intra-articular injection of meloxicam in patients suffering from TMJ internal derangement. Temporomandibular disorders (TMD) are common conditions causing pain, restricted jaw movement, and joint sounds, which can significantly impair patients' quality of life. While conventional treatments include conservative approaches and arthrocentesis alone, finding optimal therapeutic protocols remains crucial for refractory cases. A total of 50 adult patients diagnosed with unilateral TMJ internal derangement (with or without reduction) who have failed at least one month of conservative therapy will be enrolled and randomly allocated into two equal groups: Study Group: Will undergo joint arthrocentesis followed by a single intra-articular injection of meloxicam (15 mg / 1.5 mL). Control Group: Will undergo joint arthrocentesis alone using Ringer's lactate solution. Patients will be evaluated across a 12-week postoperative period (at 2, 4, 8, and 12 weeks) to assess primary and secondary outcomes, including pain intensity (measured via a Numerical Rating Scale), maximum mouth opening (inter-incisal distance in millimeters), joint sounds (clicking, popping, or crepitus), and overall patient satisfaction. The findings aim to establish whether adding an intra-articular non-steroidal anti-inflammatory drug (NSAID) enhances the therapeutic benefits of standard TMJ arthrocentesis.

Вмешательства

• Препарат Arthrocentesis with ringer lactate solution and meloxicam injection
  Intra-articular injection of 1ml of meloxical after TMJ arthrocentesis
• Препарат Arthrocentesis with ringer lactate solution
  Arthrocentesis of the TMJ with ringer lactate only

Первичные конечные точки

• Maximum Mouth Opening (MMO) [Срок оценки: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)]
• Pain intensity [Срок оценки: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)]
• Presence or Absence of Joint Sounds [Срок оценки: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)]

Вторичные конечные точки (1)

• Patient Satisfaction [Срок оценки: Recorded at the final 12-week follow-up.]

Критерии участия

Критерии включения

• Adult patients >= 18 years diagnosed clinically with unilateral TMJ internal derangement with or without reduction, based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
• Failure of conservative therapy (splint therapy, physiotherapy) for at least 1 month.
• Willing and able to provide written informed consent.

Критерии исключения

• Patients with bilateral TMJ internal derangement.
• History of TMJ surgery or major trauma on the affected side.
• Presence of rheumatic disease.
• Severe degenerative joint disease.
• Active infection around the TMJ.
• Known bleeding disorders or patients on anticoagulant therapy.
• Pregnancy or lactation.
• Allergy to Meloxicam or its components.
• Received intra-articular injections (corticosteroids, hyaluronic acid) in the TMJ within at least 3 months.

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

Ирак · 1 центр

• Al-Yarmook teaching hospital — Baghdad

Идентификаторы

NCT: NCT07743684 · 21925

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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