NCT05018234已完成不适用
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- safety of device as measured by the number of patients with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of obstructive sleep apnea
- •No active jaw joint pain
- •No active moderate to severe periodontal disease
- •Presence of 12 teeth per arch
排除标准
- •presence of severe bruxism
研究组 & 干预措施
Treatment
Experimental
干预措施: Noval Oral Appliance (Device)
结局指标
主要结局
safety of device as measured by the number of patients with adverse events
时间窗: During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2)"
次要结局
- Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey(1 month after enrollment(appointment 2))
- Comfort of the novel OA device as measured by the post care patient feedback survey(1 week after appointment 2(appointment 3))
研究者
Aaron Glick
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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