Comparative Assessment of Rhinoplastic Appliance System with and without the Integration of Intraoral Appliance in Unilateral Cleft Lip and Palate
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Comparison of intra group arch dimension and facial esthetics
研究概览
简要总结
In this study, patients with Unilateral Cleft Lip and Palate will be assessed to evaluate the outcome changes in facial esthetics and arch dimensions using Rhinoplastic Appliance system device for Presurgical Nasoalveolar Moulding with and without intraoral appliance and also assess the force vector of the appliance using Dynamic Finite Element Model.
To evaluate the effect of the appliance on nasal symmetry, 6 months post lip surgery follow up with the use of nasal appliance, RAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Month(s)（—）
- 性别
- All
入选标准
- •Non Syndromic Unilateral Cleft Lip And Palate Born at full term 0 days – 3 months infants for PSIO 3-6 months infants for post surgery follow up.
排除标准
- •Syndromic cleft lip and palate Infant with systemic diseases Infants with Simonart’s Band Parents/ guardians not providing assent.
结局指标
主要结局
Comparison of intra group arch dimension and facial esthetics
时间窗: T0 before Nasoalveolar moulding at baseline | T1 after Nasoalveolar moulding at 4 months
comparison of inter group evaluation of arch dimension and facial esthetics
时间窗: T0 before Nasoalveolar moulding at baseline | T1 after Nasoalveolar moulding at 4 months
次要结局
- Comparison of arch dimension and facial esthetics after primary lip surgery(T2 6 months after primary lip surgery)