Does Successive Intra-articular Injections of Tenoxicam or Meloxicam Affect Treatment Outcomes of Temporomandibular Joint Anterior Disc Displacement With Reduction? (A Randomized Controlled Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clicking
研究概览
简要总结
The temporomandibular joint's (TMJ) articular disc, situated between the mandibular condyle's convexity and the articular tubercle's slope, is the most intricate synovial articulation in the human body. While the usual discal position as defined by magnetic resonance imaging (MRI) places the posterior discal band at the 12 o'clock position atop the mandibular condyle's maximum convexity, this discal disposition is altered in over 30% of the population without any accompanying physical symptoms. This denotes that rather than correcting the anatomical disc position, the treatment for discal displacement would primarily focus on symptom relief.
详细描述
Up until 1975, the only treatment options for (TMJ) internal derangement were surgical procedures that involved either repositioning the articular disc or removing it. Arthroscopic lavage was first described by Ohnishi as a way to dissolve adhesions and remove the inflammatory mediators, which reduced the pain, increased the mouth opening, and increased the harmony between the mandibular condyle and the articular disc, even though their native anatomical relation was not restored. Nitzan et al. in 1991 described arthrocentesis as a conservative method for (TMJ) lavage that discarded the arthroscopic morbidity and the need for costly tools and primarily aimed to utilize the hydraulic pressure of the lavage solution to wash out the inflammatory mediators, and release the articular disc adhesions.
The direct injection of a therapeutic agent into a joint cavity is known as intra-articular injection. Which usually aims to relieve arthralgia, suppress inflammation, and enhance joint function.
Various therapeutic agents are being deposited intra-articularly, including corticosteroids, hyaluronic acid, platelet-rich plasma and fibrin, opioids, corticosteroids, anxiolytics, muscle relaxants, antidepressants, anticonvulsants, and nonsteroidal anti-inflammatory drugs (NSAIDs).
(NSAIDs) the direct inhibition of the cyclooxygenase (COX) conversion of arachidonic acid to prostaglandins has been used to treat inflammatory articular diseases.
Oxicam-derived Tenoxicam and Meloxicam are inexpensive and readily available (NSAIDs); frequently injected intraarticularly following knee arthroscopy and (TMJ) arthrocentesis by virtue of their sustained drug delivery and long-lasting inflammatory effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
An independent staff member will randomly allocate the patients into (Tx group) and (Mx group) after labeling them
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes with an age range of 18-45 years.
- •Those patients with the radiographic interpretation of unilateral or bilateral (TMJ) anterior disc displacement with reduction with the clinical signs of pain, limitation of mouth opening, and TMJ clicking; Wilkes classification type II.
排除标准
- •Clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
- •Previous (TMJ) surgery, arthrocentesis, or occlusal splints.
- •Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.
- •Those Patients with a history of allergic reactions to any components of the injectable solutions.
研究组 & 干预措施
The Study group
The study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Tenoxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction.
干预措施: intraarticular injection (Drug)
The Control group
The study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Meloxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction.
干预措施: intraarticular injection (Drug)
结局指标
主要结局
Clicking
时间窗: 9 months
Absence or presence of clicking
Visual analogue scale
时间窗: 9 months
Scale from 1 to 10 which the 10 is the worst pain
Maximal interincisal opening
时间窗: 9 months
Increase in interincisal opening
次要结局
未报告次要终点
研究者
Ahmed Nagi Alghandour
Lecturer
Beni-Suef University