NCT04331379已完成不适用
Effectiveness of Nasal-alar Elevator (NE) Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial
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
- 32
- 试验地点
- 1
- 主要终点
- Nasal Esthetics
研究概览
简要总结
This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with age range from 1-30 days.
- •Unilateral complete cleft lip and alveolus.
- •Medically free subjects.
- •Both males and females.
- •Cleft gap more than 10 mm.
排除标准
- •Patients older than 30 days.
- •Syndromic patients with other defects in addition to cleft lip and palate.
- •Patients with bilateral cleft lip and palate.
- •Incomplete Cleft lip.
- •Patient with previous surgical lip repair or adhesion.
- •Patients with previous presurgical infant orthopedic treatment.
- •Medically compromised patients.
- •Cleft gap distance less than 10mm
研究组 & 干预措施
Nasal Elevator
Experimental
干预措施: Nasal Elevator (Device)
Taping Alone
Active Comparator
干预措施: Taping Alone (Device)
结局指标
主要结局
Nasal Esthetics
时间窗: 3 months
Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software.
Maxillary arch changes
时间窗: 3 months
Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software.
次要结局
未报告次要终点
研究者
Mohamed Abd El-Ghafour
Lecturer of Orthodontics
Cairo University
研究点 (1)
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