Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 18
- 主要终点
- Successful Correction of Malocclusion
研究概览
简要总结
The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.
详细描述
This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.
The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).
The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 14 years of age.
- •Subject is willing and able to give informed consent.
- •Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
- •Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
- •Subject has good oral hygiene defined by the orthodontist.
- •Subject has only permanent dentition.
排除标准
- •Subject has skeletal discrepancies requiring surgery
- •Subject is undergoing active dental work
- •Subject has severe open bite > 2 mm
- •Subject has severe overjet > 4 mm
- •Subject has deep bite > 3 mm
- •Subject has over crowding per arch > 4 mm
- •Subject has dental prostheses/implants that will interfere with projected teeth movement
- •Subject is taking systemic steroid medication
- •Subject is taking Biphosphonates or any other medication for treatment of osteoporosis
结局指标
主要结局
Successful Correction of Malocclusion
时间窗: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Achievement of target setup per treatment plan as determined by Orthodontist.
次要结局
- Individual Tooth Movement(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Ease of Insertion(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Aligner Comfort(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Effective Use of Attachments(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Aligner Ease of Cleaning(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Mid Course Corrections/Refinements Needed(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Treatment Time for Tooth Movement(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Orthodontist Satisfaction(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Software Satisfaction(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Appearance Satisfaction(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)
- Ease of Aligner Removal(The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.)