NCT06070558招募中不适用
ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).
研究概览
简要总结
The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints.
This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult: age ≥ 18 years old;
- •Person with the capacity to understand the instructions given;
- •Person affiliated to a social security scheme or beneficiary of such a scheme;
- •Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.
排除标准
- •Person with large-scale metallic dental reconstructions;
- •Edentulism more than 5 teeth;
- •Claustrophobia;
- •Contraindication to performing an MRI examination
- •Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code
研究组 & 干预措施
Temporomandibular Joint Disorders
Other
Patients with Temporomandibular Joint Disorders
干预措施: MRI with Real Time MRI Rapid Flash sequence (Device)
Healthy
Other
Healthy volunteers
干预措施: MRI with Real Time MRI Rapid Flash sequence (Device)
结局指标
主要结局
Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).
时间窗: Baseline (day 0)
次要结局
- Curve representing the displacement of the articular discs during TMJ movements(Baseline (day 0))
- Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD(Baseline (day 0))
- Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.(Baseline (day 0))
研究者
Pedro TEIXEIRA-GONDIM, MD
Principal Investigator
Central Hospital, Nancy, France
研究点 (2)
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