Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The nasal morphology - Nostril height 1
研究概览
简要总结
Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang Gung Memorial Hospital. The objective of this study is to compare the number of clinical visits, total prices, complications and nasal symmetry between these two NAM reconstruction methods.
详细描述
Grayson's NAM reconstruction starts with alveolar molding first. The alveolar molding is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. After the alveolar cleft gap is less than 5 mm (usually at the end of second months), nasal molding was added to the alveolar molding plate.
Figueroa's NAM reconstruction use labial tapes and acrylic relief to the palatal plate to approximate alveolar gap. The device starts with nasal and alveolar molding simultaneously.
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 Week 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete unilateral cleft lip infant
- •Signed informed consent
排除标准
- •Incomplete unilateral cleft lip infant
- •Association of other craniofacial anomalies
结局指标
主要结局
The nasal morphology - Nostril height 1
时间窗: (T1) at initial visit
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril height 2
时间窗: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - - Nostril height 3
时间窗: (T3) one week after surgery
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril height 4
时间窗: (T4) 6 months after surgery
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril width 1
时间窗: (T1) at initial visit
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 2
时间窗: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 3
时间窗: (T3) one week after surgery
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 4
时间窗: (T4) 6 months after surgery
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nasal sill height 3
时间窗: (T3) one week after surgery
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
The nasal morphology - Nasal sill height 4
时间窗: (T4) 6 months after surgery
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
The nasal morphology - nostril area 1
时间窗: (T1) at initial visit
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 2
时间窗: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 3
时间窗: (T3) one week after surgery
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 4
时间窗: (T4) 6 months after surgery
Nostril area: the area presented by nostril aperture.
次要结局
- duration of NAM(From initial of nasoalveolar molding to finish of nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old))
- total number of visits before surgical correction(From the initial visit to the date of surgery (participants' surgery will be performed on 3-month of age))
- cost of treatment(From initial orthodontic visit to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old))
- NAM complications(From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old))