The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.
研究概览
简要总结
The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.
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
- 11 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent dentition
- •Class I malocclusion with irregularity score of greater than 2 mm in either arch
- •Good oral hygiene
排除标准
- •Any medical or dental condition that could potentially affect study results
- •Patients currently using any investigational drug or any other investigational device
- •Patients planning to relocate or move during the treatment period
- •Use of bisphosphonates
- •Pregnant females
研究组 & 干预措施
Extraoral OrthoPulse® PBM
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
干预措施: Extraoral OrthoPulse® PBM (Device)
Extraoral OrthoPulse® PBM
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
干预措施: Fixed Orthodontic Appliance Treatment (Other)
Orthodontic Treatment (Control)
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
干预措施: Fixed Orthodontic Appliance Treatment (Other)
结局指标
主要结局
Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.
时间窗: Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.
次要结局
未报告次要终点