NCT06651944招募中不适用
Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Comfort and fit
研究概览
简要总结
The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be eligible for Invisalign treatment with mandibular advancement
排除标准
- •Subject's dentition not compatible with device or allergy to device materials
- •Subject who is pregnant, has active caries, periodontal disease, TMD, root resorption, has HAE (hereditary angioedema), has been diagnosed with epilepsy or any other seizure disorder
结局指标
主要结局
Comfort and fit
时间窗: Through the study completion of up to 2 years
Measured using quality of life surveys at the insertion, interim, and end of study visits. Measured on a scale which the subject rates from 1-Always to 5-Never on their current experience.
次要结局
- Class II correction(Through the study completion of up to 2 years)
研究者
研究点 (6)
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