RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The rate of orthodontic tooth movement
研究概览
简要总结
This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.
A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.
All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must be 19 years of age or older
- •Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
- •Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data
排除标准
- •Patient is currently enrolled in another clinical study
- •Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
- •Periodontally involved teeth, acute oral infection or periodontal disease
- •Patient has active/untreated caries
- •Use of bisphosphonates at any time
- •Use of drugs that may cause photosensitivity
- •History of photosensitivity
- •Pregnant or planning pregnancy during the study.
- •Patient plans to relocate over the treatment period
结局指标
主要结局
The rate of orthodontic tooth movement
时间窗: 36 days (±12 days) from T0 visit
The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week).
次要结局
- Peak Pain: Questionnaire(7 Days)
- Root Resorption(36 days (±12 days) from T0 visit)
- Initial Safety of Device(From enrolment to study completion, anticipated six (6) months)