OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- Feedback on general experience
研究概览
简要总结
OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent must be obtained before any assessment is performed
- •Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
- •Presence of permanent dentition
- •Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
- •Good oral hygiene
- •Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
- •Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data
排除标准
- •Patient is currently enrolled in another clinical study
- •Periodontally involved teeth, acute oral infection or periodontal disease
- •Use of bisphosphonates (osteoporosis drugs) during the study
- •Use of drugs that may cause photosensitivity
- •History of photosensitivity
- •History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
- •Patient plans to relocate over the treatment period
- •Smoker or use of any tobacco containing products per the discretion of the PI
研究组 & 干预措施
I-OP2.0
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
干预措施: OrthoPulse 2.0 (Device)
I-OP2.0
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
干预措施: Invisalign 3.5 Day Wear (Device)
I-OP2.1
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
干预措施: OrthoPulse 2.1 (Device)
I-OP2.1
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
干预措施: Invisalign 3.5 Day Wear (Device)
F-OP2.0
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
干预措施: OrthoPulse 2.0 (Device)
F-OP2.0
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
干预措施: Fixed Orthodontic Appliances (Braces) (Device)
结局指标
主要结局
Feedback on general experience
时间窗: Through Study Completion, approx. 2 years
Assess doctor and patient feedback on the general experience with OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.
Feedback on clinical performance
时间窗: Through Study Completion, approx. 2 years
Assess doctor subjective and objective feedback on the clinical performance of OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.
Adverse events
时间窗: Through Study Completion, approx. 2 years
Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1
次要结局
未报告次要终点