Evaluation of 3D Printed Aligners for Nasoalveolar Molding in Infants Born With Unilateral Complete Cleft Lip and Palate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- approximation of segments of maxillary arch
研究概览
简要总结
study will provide nasoalveolar molding (NAM) treatment, special care for infants born with cleft lip and palate. This novel appliance will help to provide the care in accurate and easy form by help of both digital work flow and new material which provide a unique properties.
详细描述
A sample of 10 infants born with unilateral cleft lip and palate (UCLP) ranging in age from seven to 45 days who meet the inclusion criteria will be recruited and subjected to the following study procedures: maxillary impression, extraoral scanning for nasolabial area and facial photos.
For digital workflow; the following steps will be done:
- Digital model preparation.
- Model segmentation and modification.
- Virtual treatment simulation.
- Virtual appliance construction.
- Three-dimensional aligner printing.
After aligners printing, each infant will be delivered his own set of aligners. The nasal stent will be fixed to the aligner then delivered with a meticulous demonstration for parents regarding adhesive placement, insertion, and removal. Parents will be instructed to remove the aligner once per day for proper cleaning.
Infants will be followed up every two weeks till maxillary arch segments approximation and improvement of nasolabial tissue morphology. Finally, post-treatment records will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 45 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-syndromic complete unilateral cleft lip, alveolus, and palate.
- •Age is up to 45 days.
- •Cleft size more than 5mm between anterior margins of cleft segments.
排除标准
- •Infants are diagnosed with other congenital malformations.
- •Parents refusing NAM treatment.
- •Parents are unable to attend the clinic every 2 weeks.
- •Infants are born with another form of clefts like facial and median clefts.
研究组 & 干预措施
infants born with complete unilateral cleft lip and palate
photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for nasoalveolar molding treatment
干预措施: : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment (Device)
结局指标
主要结局
approximation of segments of maxillary arch
时间窗: almost 1.5 month
measuring the alveolar cleft size before and after the treatment to assess the amount of cleft reduction on the scanned models in millimeter
次要结局
未报告次要终点
研究者
Maha Sabry Sayed
assistant lecturer
Ain Shams University