Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- maximal interincisal opening (MIO)
研究概览
简要总结
The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney
详细描述
Clarification (July 2025): Recruitment was completed in March 2023 following clinical scheduling and preliminary departmental clearance, while formal written ethical approval was finalized in early April 2023. All patients were followed up for one year, and the study was completed by March 2024.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with TMJ internal derangement with reduction
排除标准
- •inflammatory or connective tissue disease
- •autoimmune disease history
- •neurologic problems
研究组 & 干预措施
Intra-articular injection with MESNA solution
1 ml of MESNA will be injected intra-articular
干预措施: Mesna Injection (Drug)
Arthrocentesis with ringer solution
ringer solution will be used for arthrocentesis
干预措施: Arthrocentesis with ringer solution (Drug)
结局指标
主要结局
maximal interincisal opening (MIO)
时间窗: 6 months
a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative
次要结局
- Joint pain(6 months)
- clicking sound(6 months)
研究者
Ahmed Abdellatif Abdelfatah
Lecturer of oral and maxillofacial surgery
Tanta University