The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
研究概览
简要总结
The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.
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
- 是
入选标准
- •Presence of permanent dentition
- •Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment
- •Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
- •Class I or Class II malocclusion by ½ cusp or less
- •Non-extraction in both arches
- •Age 11-60
- •Good oral hygiene
- •Non-smoker; non-use of chewing tobacco
排除标准
- •Subject is currently enrolled in another clinical study
- •Subject decided on Invisalign rather than braces
- •Periodontally involved teeth
- •Use of bisphosphonates (osteoporosis drugs) during the study
- •Subject plans to relocate over the treatment period
- •Spaces between anterior teeth
- •Subject has dental implants or an implanted prosthesis
- •Sponsor employees, the Investigator and staff, as well as their immediate family members
研究组 & 干预措施
Group 1 (Control)
Subjects assigned to this group receive fixed appliance orthodontic treatment only
干预措施: Fixed Appliance Orthodontic Treatment (Device)
Group 2 (OP1)
Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
干预措施: Fixed Appliance Orthodontic Treatment (Device)
Group 2 (OP1)
Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
干预措施: OrthoPulse™ (Device)
结局指标
主要结局
Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
时间窗: From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment.
Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator.
次要结局
- Risk of OrthoPulse PBM to the patient.(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)
- Effect of OrthoPulse PBM on external apical root resorption (EARR)(6 months after the start of orthodontic treatment)