The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
研究概览
简要总结
This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.
详细描述
The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.
The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.
The study also aims to collect confirmatory evidence on the safety of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible and scheduled for full mouth fixed orthodontic treatment
- •Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
- •Class I or Class II by 1/2 cusp or less
- •Non-extraction in both arches
- •Age 11- 60
- •Good oral hygiene
- •Non-smokerInclud
排除标准
- •Pregnant females
- •Patient is currently enrolled in another clinical study
- •Patient decided on Invisalign® rather than braces
- •Periodontally involved teeth
- •Use of bisphosphonates (osteoporosis drugs) during the study
- •Patient plans to move over the treatment period
- •Spaces between anterior teeth
研究组 & 干预措施
Fixed Orthodontic Treatment with OrthoPulse™
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
干预措施: OrthoPulse™ (Device)
Fixed Orthodontic Treatment with OrthoPulse™
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
干预措施: Orthodontic Treatment (Other)
Fixed Orthodontic Treatment
Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.
干预措施: Orthodontic Treatment (Other)
结局指标
主要结局
Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
时间窗: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.
Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.
次要结局
- Safety Evidence of OrthoPulse™ Use(Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.)
- Degree of External Apical Root Resorption (EARR)(Assessed at six (6) months or later after starting treatment, up to two (2) years.)