Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs. Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nasolabial esthetics
研究概览
简要总结
Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.
The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.
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
- — 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 palate
- •Medically free subjects.
- •Both males and females.
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.
结局指标
主要结局
Nasolabial esthetics
时间窗: 3 months
Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention. This will be performed on a 3D scan for the infants and through calibrated photographs
次要结局
- Maxillary arch changes(3 months)
研究者
Hana Adel Adawy
Hana Adawy, Principal Investigator
Cairo University