OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- comfort of the device
研究概览
简要总结
The aim of the study is to validate a novel sensor intended to measure the wearing time of orthodontic elastics in patients with multibracket appliances. The newly developped sensor will be tested in 42 patients over a period of 6 months
详细描述
Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually, elastics are inserted between the upper and lower jaws to adjust the position of the jaws in relation to each other. The wearing time of the elastics determines the duration of the treatment and the quality of the treatment results. While micro-sensors are increasingly used for removable appliances to monitor patient compliance, there is still no such possibility for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral mini-sensor). This is intended to measure and record the wearing time of the elastics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multibracket appliances (fixed braces) in both jaws
- •Need for intermaxillary elastics on at least one side
- •Minimum motor skills
排除标准
- •Patients with general diseases
- •Patients with inflammatory oral diseases
- •Patients with physical disabilities, which make it impossible to cooperate
- •Independent insertion of the elastics is not possible
- •Patients with impaired judgment Pregnant women
结局指标
主要结局
comfort of the device
时间窗: 6 months
The wearing comfort for the patient is ok/not ok
Handling of the device
时间窗: 6 months
The handling for the therapist is ok/not ok
次要结局
- cooperation(6 months)