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临床试验/NCT05027243
NCT05027243已完成不适用

Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results

Instituto Portugues da Face0 个研究点目标入组 46 人开始时间: 2016年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
主要终点
Pain (Visual Analogue Scale (0,10)

研究概览

简要总结

Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.

详细描述

Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. It was first introduced by Onishi at 1975, as a pioneering technique to treat painful joints and has been associated with a reduction in the number of open joints surgeries. This minimally invasive technique allows observation of the TMJ upper compartment tissues, and sometimes the lower compartment. Moreover, this intervention allows joint lysis and lavage (level 1 arthroscopy) and intra-articular surgical procedures (level 2-3 arthroscopy).

Recent studies updated that TMJ arthroscopy promotes a reduction in pain and inflammatory process and restoring the mandibular function with low morbidity. Moreover, TMJ arthroscopy seems to be also long-term effective for relieving TMJ symptoms. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >16 years;
  • clinical diagnosis of bilateral intra-articular disorder;
  • clinical criteria for bilateral TMJ arthroscopy;
  • magnetic resonance imaging (MRI) assessing the intra-articular derangement

排除标准

  • The exclusion criteria included any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks prior the study.
  • Severe medical problems or mental illness, and pregnancy were also exclusion criteria

研究组 & 干预措施

bilateral temporomandibular joint arthroscopy

Experimental

干预措施: bilateral temporomandibular joint arthroscopy (Procedure)

bilateral temporomandibular joint arthroscopy

Experimental

干预措施: Xeomin® (Merz) (Drug)

结局指标

主要结局

Pain (Visual Analogue Scale (0,10)

时间窗: Through study completion, an average of 2.5 years

VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

次要结局

  • Muscle tenderness (0-3 scale)(Through study completion, an average of 2.5 years)
  • Maximum mouth opening (MMO, mm)(Through study completion, an average of 2.5 years)

研究者

发起方
Instituto Portugues da Face
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Faustino Ângelo

Clinical Director

Instituto Portugues da Face

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