Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- study models
研究概览
简要总结
The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on "High-Tech" technology.
The appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-D screening technology of the patient's malocclusion. The aligner has a designed pathway "built-in" for the tooth to move, from the original position of the malocclusion to the "end point" - the correct position.
The force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner.
The study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.
详细描述
The appliance include:
- silicone aligner (made specifically for the patient.
- simple air pump to blow air in the tiny balloons.
The patient is guided to wear the appliance 12-14 hours a day, after filling air in the balloons, under the doctor's instructions.
Clinical examination for follow-up will be done every 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 68 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild to moderate class I malocclusion
- •good general health
- •good oral hygiene
排除标准
- •bad cooperation
- •any mental or health problem
- •severe class I malocclusion, class II or class III malocclusion
结局指标
主要结局
study models
时间窗: every 2 appointments (8 weeks)
次要结局
- occlusal photographs(every 3 appointments (12 weeks))