Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
研究概览
简要总结
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.
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
- 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
- 否
入选标准
- •Presence of permanent dentition
- •Eligible and scheduled for full mouth fixed orthodontic treatment.
- •Class I or Class II malocclusion (no more than ½ cusp in Class II)
- •Non-extraction in all quadrants
- •Non-smoker, non-use of chewing tobacco
- •Good oral hygiene
- •No adjunct treatment such as extra or intraoral appliances
- •Age 12-40
排除标准
- •Pregnant females
- •Patient is currently enrolled in another clinical study
- •Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
- •Periodontally involved teeth
- •Use of bisphosphonates
- •Unerupted erupted teeth
- •Teeth blocked out of alignment and unable to engage initial arch wire
研究组 & 干预措施
OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
干预措施: OrthoPulse™ (Device)
OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
干预措施: Fixed Orthodontic Appliance Treatment (Other)
Sham-Control OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
干预措施: Fixed Orthodontic Appliance Treatment (Other)
Sham-Control OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
干预措施: Non-Functional OrthoPulse™ (Device)
结局指标
主要结局
Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
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.
The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.
次要结局
未报告次要终点