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临床试验/NCT06473376
NCT06473376已完成不适用

Comparison Between of Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
change in pain using a visual analog scale,

研究概览

简要总结

This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.

详细描述

This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders. The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes.

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

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with TMJ closed lock confirmed

排除标准

  • rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy

结局指标

主要结局

change in pain using a visual analog scale,

时间窗: one year

The primary outcome variable was the change in pain using a visual analog scale (VAS), with 0 indicating the absence of pain and 10 indicating the worst pain possible

improvement of maximum voluntary mouth opening

时间窗: one year

improvement of maximum voluntary (non-assisted) mouth opening (MVMO) in millimetres.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Hegab

Prof. Ayman Hegab

Al-Azhar University

研究点 (2)

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