The Effect of Ultrasound on Orthodontic Tooth Movement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Rate of Tooth Movement
研究概览
简要总结
To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
详细描述
The study will involve comparing the effects of tooth movement with and without ultrasound treatment in a split mouth design. Treatment will consist of using the Aevo System™ device for one 20 minute period per day for the duration of the trial (up to 24 weeks). Tooth position measurements will be taken from eligible patients prior to commencing usage of the study device. Follow-up visits will be scheduled for intra-oral clinical measurements and to take full-arch impressions. The Aevo System™ consists of an ultrasound emitting mouthpiece which is wire connected to an external handheld device. The mouthpiece is placed over the teeth and over the braces every day for 20 minutes in order to deliver the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Subjects who meet all of the following criteria will qualify for entry into the study:
- •Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
- •Minimum of 3 mm of extraction space (on both sides of a dental arch) to be closed either by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines.
- •Available for follow-up visits.
- •Willing and able to sign written informed consent.
- •Has permanent dentition and between the ages of 12 and
- •Good oral hygiene and compliance
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
- •Any implanted assistive devices.
- •Currently involved in any other study.
- •Lives significantly outside the clinical trial site.
- •Use of bisphosphonates.
- •Pregnant females .
结局指标
主要结局
Rate of Tooth Movement
时间窗: 24 weeks or until the extraction space was closed (whichever came first)
The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.
次要结局
- Rate of Root Resorption(24 weeks or until the extraction space was closed (whichever came first))
- Discomfort(24 weeks or until the extraction space was closed (whichever came first))