Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in the maxillary arch
研究概览
简要总结
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.
详细描述
The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.
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)
盲法说明
single blinded
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-syndromic Infants with complete BCLP infants
- •Infants less than 1 month of age
- •Males and females.
- •Infants with displaced premaxilla
- •Patients whose parents provided written consent for the study.
排除标准
- •Patients above 1 month of age
- •Syndromic and systemically ill infants.
- •Patients with unilateral cleft lip and palate.
- •Incomplete Cleft lip.
- •Medically compromised patients
- •Patient's/guardians who will be unwilling to go through the PNAM therapy
结局指标
主要结局
Changes in the maxillary arch
时间窗: T1 and T2 (4- 6 months)
they will be measured in mm by digital models
次要结局
未报告次要终点
研究者
Khadega Ali Al Khateeb
Phd student, faculty of Dentistry, Cairo university
Cairo University