Class II Correction Study Using the Invisalign System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 18
- 主要终点
- Rate of Tooth Movement at the End of Class II Correction.
研究概览
简要总结
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have fully erupted dentition excluding 2nd and 3rd molars
- •Age range 11-19 years old
- •Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship
排除标准
- •Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- •Subject who has spaces between adjacent teeth larger than 3mm
- •Subject with active caries
- •Subject with periodontal disease
- •Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
- •Subject with TMD (Temporomandibular joint dysfunction) symptoms
- •Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
- •Subject has known allergy to latex and plastic
- •Subjects who are pregnant or will become pregnant during treatment
结局指标
主要结局
Rate of Tooth Movement at the End of Class II Correction.
时间窗: End of Class II Correction up to 18 months
The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month).
次要结局
- Length of Treatment Time(End of Treatment approximately 2 years)
- Doctor Survey for Satisfaction With Treatment Outcomes(End of Treatment approximately 2 years)
- Patient Quality of Life Questionnaire Throughout Treatment(End of Treatment approximately 2 years)