Investigation of the Effect of a Customized Nasal Brace on Nasal Deformities With or Without Prior Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Broad nose: Appealing proportion of nose width to eye-corner distance.
研究概览
简要总结
Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery.
- Trial with medicinal product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups
排除标准
- •Inability to keep the research plan
- •Allergies to components of the nasal brace
- •Diseases of the bone metabolism
- •Medication affecting bone metabolism
- •Drugs or alcohol abuse
研究组 & 干预措施
Surgery plus device (Nasella)
Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.
干预措施: Use of customized nasal brace (Nasella) for nose deformities (Device)
Surgery plus device (Nasella)
Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.
干预措施: corrective surgery (Procedure)
Surgery, no device thereafter
Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) .
干预措施: corrective surgery (Procedure)
Only device (Nasella)
No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason).
干预措施: Use of customized nasal brace (Nasella) for nose deformities (Device)
结局指标
主要结局
Broad nose: Appealing proportion of nose width to eye-corner distance.
时间窗: 14 months of treatment with Nasella
The improvement of proportion of width compare to study start
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
时间窗: 14 months of treatment with Nasella
The improvement in degrees compared to study start
Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).
时间窗: 14 months of treatment with Nasella
The improvement in degrees compared to study start
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
时间窗: 9 Weeks after surgery
The deviation from a perfect line (0 axis) is measured and compared to control group
Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).
时间窗: 9 Weeks after surgery
The deviation from a perfect line (0 axis) is measured and compared to control group
Broad nose: Appealing proportion of nose width to eye-corner distance.
时间窗: 9 weeks after surgery
The deviation from a perfect line (0 axis) is measured and compared to control group
次要结局
- Doctors assessment of various appearances(14 months after treatment)
- Subjective Satisfaction(14 months of treatment)
- Subjective Satisfaction(9 weeks postoperatively)
- Doctors assessment of various appearances(9 weeks postoperatively)