NCT04369638终止不适用
Fabrication of NAM Appliance in CLP From Digital MRI Face Scan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Fit as measured by number of adjustments to the device
研究概览
简要总结
The purpose of this study is to fabricate a nasoalveolar molding (NAM) appliance that is digitally fabricated and 3 dimensionally printed utilizing an MRI face scan and to assess the fit of the NAM in new borns with cleft lip and palate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •new born babies with cleft lip and/or palate
- •will undergo treatment with UT Pediatric Dental Clinic with a NAM appliance
排除标准
- •Patients without cleft lip and/or palate
- •patients that cannot tolerate an intraoral appliance
- •patients that are not able to be discharged from the hospital 2-3 days after birth.
结局指标
主要结局
Fit as measured by number of adjustments to the device
时间窗: One month after MRI
次要结局
未报告次要终点
研究者
Brett Thomas Chiquet
Resident
The University of Texas Health Science Center, Houston
研究点 (2)
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