A Clinical Evaluation of Orthodontic Tooth Movements in Mixed Dentition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- The primary endpoint will assess the tooth movements (torque, extrusion, rotation, translation, intrusions, and tipping), ensuring that final dentition is within 0.3 mm of the intended position.
研究概览
简要总结
This study will examine shortened treatment wear time for patients with mixed dentition using sequential dental aligners. Using the existing AirFlex aligner design that patients with permanent dentition use, it may be possible to reduce the wear time and still provide dental realignment in an adequate treatment period for patients with mixed dentition. The Airflex aligner will be tested for a 9-12-hour patient wear time.
详细描述
The primary intervention is the change in active wear time. In current practice, sequential aligners are prescribed to be worn approximately 20 to 22 hours per day. In this study, the prescribed wear time will be reduced to 9 - 12 hours per day.
This study is intended to demonstrate effectiveness of AirFlex aligners, which have a reduced wear time compared to traditional aligners, in mixed dentition subjects. The study will be conducted using AirFlex aligners, which are currently cleared for treatment of patients with permanent dentition.
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
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 7 to 21 years old
- •Mixed dentition, as defined by the presence of at least one primary tooth present at the start of orthodontic treatment
- •No untreated cavities
- •Good Periodontal composition as determined by dental exam
排除标准
- •Skeletal discrepancies requiring surgery
- •Is currently undergoing dental/orthodontic work
- •Has dental prosthesis/implants that will interfere with projected tooth movement
- •Ongoing use of medication affecting tooth movement or bone formation (NSAIDS, Steroids, Bisphosphonates, Levothyroxine, Teriparatides, etc.)
- •Is currently pregnant or plans to become pregnant during treatment
- •Current smoker or tobacco use within 2 years
- •Presence of systemic diseases that could interfere with treatment
- •Moderate or significant periodontal disease
- •Any other physical exam finding that precludes participation
结局指标
主要结局
The primary endpoint will assess the tooth movements (torque, extrusion, rotation, translation, intrusions, and tipping), ensuring that final dentition is within 0.3 mm of the intended position.
时间窗: 16 weeks
次要结局
未报告次要终点