Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Parents' satisfaction
研究概览
简要总结
The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.
详细描述
In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.
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
- 7 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with age range from 7 - 30 days.
- •Unilateral complete cleft lip and alveolus.
- •Presence of unilateral cleft 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.
- •Medically compromised patients.
研究组 & 干预措施
Modified Nasoalveolar molding group
This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.
干预措施: Modified Nasoalveolar molding (Device)
Taping group
Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.
干预措施: Taping (Device)
Control group
This group will not receive any treatment.
CAD/NAM group
Computer Aided Designed Nasoalveolar molding and 3D printed.
干预措施: CAD/NAM (Device)
结局指标
主要结局
Parents' satisfaction
时间窗: 3 months
It will be assessed using Questionnaire.
次要结局
- Nasal Esthetics: d- Nostril area(3 months)
- Maxillary Arch Dimension(3 months)
- Nasal Esthetics: a- Nostril height(3 months)
- Nasal Esthetics: b- Nostril width(3 months)
- Nasal Esthetics: c- Nasal sill height(3 months)
- Interlabial gap(3 months)
研究者
Mohamed Abd El-Ghafour
Assistant lecturer
Cairo University