The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 167
- 试验地点
- 8
- 主要终点
- Rate of tooth movement
研究概览
简要总结
The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Invisalign "Full Treatment" product only
- •Have a permanent dentition
- •18 years-old
- •Angle Class I or ½ cusp Class II molar and canine relationship
- •Moderate to mild crowding in at least one arch
排除标准
- •Subjects who do not fulfill all inclusion criteria requirements
- •Craniofacial anomaly present
- •Past or present signs and symptoms of periodontal disease
- •A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
- •Previous orthodontic or orthopedic relapse within 1 year
- •History of trauma, bruxism, or parafunction
- •Skeletal jaw discrepancy
- •Use of osteoporosis drugs
- •Initial use of auxiliary mechanics such as elastics
结局指标
主要结局
Rate of tooth movement
时间窗: From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years
Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment.
次要结局
- Length of treatment time(From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years)
- Effect of photobiomodulation on external apical root resorption(From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years)