Primer Aligner Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 38
- 主要终点
- Total Treatment Time
研究概览
简要总结
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
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. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Subject must have fully erupted dentition
- •Age range ≥18 years old (Adult subject)
- •Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets
排除标准
- •Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- •Subject who has mixed dentition
- •Subject with periodontal disease
- •Subject with active caries
- •Subject with Temporomandibular Joint Disorders symptoms
- •Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
- •Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
- •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
Total Treatment Time
时间窗: Approximately 1 year
Total treatment time was measured in days. The less days a subject was in treatment, the better.
Rate of Refinement
时间窗: Approximately 1 year
Rate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.
次要结局
未报告次要终点