Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Maximum Mouth Opening (MMO)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Meloxicam
Arthrocentesis with ringer lactate solution and meloxicam injection
干预措施: Arthrocentesis with ringer lactate solution and meloxicam injection (Drug)
Control
Arthrocentesis with ringer lactate solution only
干预措施: Arthrocentesis with ringer lactate solution (Drug)
结局指标
主要结局
Maximum Mouth Opening (MMO)
时间窗: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Inter-incisal distance measured in millimeters using a digital caliper or standard ruler.
Presence or Absence of Joint Sounds
时间窗: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Clinical examination evaluating the TMJ for joint sounds such as clicking, popping noise, or crepitus.
Pain intensity
时间窗: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Measured using a 0-10 pain numerical rating scale , where 0 equals no pain and 10 equals the worst pain possible. The score indicates the degree of pain experienced by the patient by the patient at the baseline evaluation. Minimum score is 0, and the maximum score is 10. During the follow-up visits , decreasing pain score indicates better outcome, while increasing pain score indicates worse outcome.
次要结局
- Patient Satisfaction(Recorded at the final 12-week follow-up.)
研究者
Hussein Mohammed Ridha
Principal investigator
Yarmook Hospital
