Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Nasolabial esthetics
研究概览
简要总结
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.
详细描述
The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while 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)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 or Simonart band (soft tissue bridge at the cleft side).
- •Medically compromised patients
- •Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.
结局指标
主要结局
Nasolabial esthetics
时间窗: 4-6 months
Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.
次要结局
- Maxillary arch changes(4-6 months)
研究者
: Donia Ayman Ahmed Ezzeldin ElSayed
Assistant lecturer at Orthodontic Department, Cairo University
Cairo University