跳至主要内容
临床试验/NCT03305315
NCT03305315已完成不适用

Study of Movement of the Pathological Temporomandibular Joint.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年12月12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
15
试验地点
1
主要终点
Mobility of the jaw with regard to the skull during each movement.

研究概览

简要总结

Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. The first step is to determine whether 3D kinematic quantification of the mandible would make it possible to objectively assess the effect of post-operative management on TMJ function recovery. If the first results are encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the investigators will evaluate the feasibility of kinematic assessments for major TMJ dysfunctions and for the follow-up of patients.

The expected benefits of this study are to be considered in the medium term and concern the possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patients who have provided verbal consent,
  • Patients over 18 years old,
  • Patients with mandible dentition compatible with placement of the kinetic measurement device,
  • Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of the mandible requiring mandible implants or a TMJ prosthesis).
  • Asymptomatic subjects:
  • Subjects who have provided verbal consent,
  • Subjects over 18 years old,
  • Subjects with Class 1 occlusion,
  • Subjects without dental implants,
  • Subjects with no history of joint dysfunction,
  • Absence of clicking, popping, or grating sounds during large movements and during palpation of the TMJ with the mouth slightly open (distance between incisors around 1 cm)
  • Absence of headache,
  • Absence of tinnitus,
  • Kinematic curves around the mean.

排除标准

  • Adults under guardianship,
  • Patients without national health insurance cover.

结局指标

主要结局

Mobility of the jaw with regard to the skull during each movement.

时间窗: Until 6 months post-surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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