INNOVATIVE CONTRIBUTIONS OF A 4D VIRTUAL SIMULATOR (Modjaw®) IN THE MANAGEMENT OF TEMPOROMANDIBULAR JOINT DISORDERS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- presence of a step in reducible disc displacement (length)
研究概览
简要总结
Temporomandibular disorders (TMD) encompass all temporomandibular muscular and osteoarticular conditions.
TMD affects 31% of the adult population, with chronic, debilitating pain in 10% of cases. Clinical diagnosis remains complex, and patients are underdiagnosed, whereas early management of these disorders can prevent worsening and significant public health expenditure.
The Modjaw device, which is integrated into modern digital workflows in dental surgery-particularly for the manufacture of prostheses-could enable systematic joint diagnosis through the automatic interpretation of tracings. The validity of interpreting condylar tracings obtained via axiography (compared to MRI, considered the gold standard) for diagnosing disc displacement in the TMJ has been demonstrated. The team recently demonstrated the reproducibility of Modjaw® condylar recordings from healthy patients, as well as the reliability of the recordings. However, to date, the evaluation of this device has not focused on its added potential in terms of assisting the clinician in diagnosing disc displacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •positive result on the validated questionnaire for the screening of disc displacement;
- •referral for an MRI scan of the TMJs for diagnostic confirmation
- •signed informed consent form
- •membership of a social security scheme
排除标准
- •Patients who do not speak or understand French;
- •Pregnant women;
- •Patients who have refused an MRI scan or for whom an MRI scan is contraindicated.
- •Vulnerable patients, minors, patients under guardianship or trusteeship, or those protected by law.
研究组 & 干预措施
MODJAW®
Modjaw® record
干预措施: digital jaw impressions and Modjaw® records (Other)
结局指标
主要结局
presence of a step in reducible disc displacement (length)
时间窗: at inclusion
the length between the curves, which will be examined to determine their ability to distinguish between DTM1 and MRI (in mm)
presence of a step in reducible disc displacement (vertical spacing)
时间窗: at inclusion
the vertical spacing between the curves, which will be examined to determine their ability to distinguish between DTM1 and MRI (in mm)
次要结局
未报告次要终点