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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Grayson NAM
Figueroa NAM
Chun-Shin, Chang
Taipei, Taiwan, Taiwan
The nasal morphology - Nostril height 1
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time frame: (T1) at initial visit
The nasal morphology - Nostril height 2
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time frame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
The nasal morphology - - Nostril height 3
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time frame: (T3) one week after surgery
The nasal morphology - Nostril height 4
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time frame: (T4) 6 months after surgery
The nasal morphology - Nostril width 1
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time frame: (T1) at initial visit
The nasal morphology - Nostril width 2
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time frame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
The nasal morphology - Nostril width 3
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
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Time frame: (T3) one week after surgery
The nasal morphology - Nostril width 4
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time frame: (T4) 6 months after surgery
The nasal morphology - Nasal sill height 3
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
Time frame: (T3) one week after surgery
The nasal morphology - Nasal sill height 4
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
Time frame: (T4) 6 months after surgery
The nasal morphology - nostril area 1
Nostril area: the area presented by nostril aperture.
Time frame: (T1) at initial visit
The nasal morphology - nostril area 2
Nostril area: the area presented by nostril aperture.
Time frame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
The nasal morphology - nostril area 3
Nostril area: the area presented by nostril aperture.
Time frame: (T3) one week after surgery
The nasal morphology - nostril area 4
Nostril area: the area presented by nostril aperture.
Time frame: (T4) 6 months after surgery
duration of NAM
Duration of NAM = Operation date - NAM initiation date
Time frame: 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
Total number of orthodontic visit or NAM adjustment = number of adjustment of NAM
Time frame: From the initial visit to the date of surgery (participants' surgery will be performed on 3-month of age)
cost of treatment
Cost = cost of each visit of orthodontic and adjustment of NAM before surgery
Time frame: 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
Any complication like mucosa ulceration and facial skin irritation
Time frame: From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)