One Week Aligner Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 24
- 主要终点
- Planned to Final Tooth Position
研究概览
简要总结
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
详细描述
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have fully erupted dentition except for 2nd and 3rd molars
- •For Teen treatment group, subjects ages <17 years of age
- •For Adult treatment group, subjects ≥17 years of age
排除标准
- •Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
- •Subject with active caries
- •Subject with periodontal disease
- •Subject with TMD symptoms
- •Subject has known allergy to latex or plastic
- •Subjects who are pregnant or will become pregnant during treatment
结局指标
主要结局
Planned to Final Tooth Position
时间窗: Through study completion, an average of 2 years
Test vs Historical Control Group
次要结局
- Treatment time(Through study completion, an average of 2 years)
- Subject Quality of Life(Through study completion, an average of 2 years)