Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Alveolar alignment
研究概览
简要总结
Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
入排标准
- 年龄范围
- 7 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral cleft lip and palate
排除标准
- •Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
研究组 & 干预措施
Naso-alveolar molding (NAM)
Active plates and nasal stents (Grayson method)
干预措施: Naso-alveolar molding (NAM) (Device)
Computer aided design NAM (CAD/NAM)
Computer aided design active plates and nasal stents
干预措施: Computer aided design NAM (CAD/NAM) (Device)
结局指标
主要结局
Alveolar alignment
时间窗: 5-6 months
Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments
次要结局
- Nasal and labial esthetics(5-6 months)
研究者
Noha Ali El Ashmawi
Assistant lecturer at orthodontic department
Cairo University