The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
研究概览
简要总结
To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).
详细描述
This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent dentition between the ages of 12 and 40
- •Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines
- •Good oral hygiene and compliance
排除标准
- •Any compromised medical or dental condition
- •Patient currently involved in any other study
- •Lives significantly outside San Antonio, TX
- •use of bisphosphonates
- •pregnant females
研究组 & 干预措施
Sham Device (inactive device)
Sham device will look identical to active devices but will not deliver vibration to the patient.
干预措施: Sham Device (Device)
OrthoAccel Device
Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
干预措施: OrthoAccel Device (Device)
结局指标
主要结局
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
时间窗: Time to Space Closure, an average of 22 weeks
次要结局
未报告次要终点