Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Nasolabial Groove Angle
研究概览
简要总结
The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side .
- Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle.
- Evaluation of degree of similarity using esthetic scales at six months postoperative.
Participants will receive nasal conformers intraoperative with follow up of 6 months.
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
- None
入排标准
- 年龄范围
- 10 Weeks 至 24 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes with unilateral cleft lip.
- •Age range 10 - 24 weeks.
- •Hemoglobin more than 10 gm/dl .
- •Weight more than 10 lbs.
排除标准
- •Syndromic patients.
- •Patients with conditions contradicting operation.
- •Patients with Bilateral cleft lip.
- •Patients with previous surgeries in lip and nose.
结局指标
主要结局
Nasolabial Groove Angle
时间窗: 6 months
To assess the flare of the nasal alar base, the angle between a line tangential to the outer alar basepoint and the horizontal reference line was measured in degrees.
Nostril height
时间窗: 6 months
The greatest vertical distance of the nostril in millimeters .
Nostril width
时间窗: 6 months
This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters.
Columellar Deviation Angle
时间窗: 6 months
The midline columellar deviation from the vertical reference line was measured in degrees.
次要结局
未报告次要终点
研究者
Mahmoud Akram
Assistant lecturer of Oral and Maxillofacial surgery
Alexandria University