Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unilateral Complete Cleft Lip
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The nasal morphology - Nostril height 1
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Complete unilateral cleft lip infant
- •Signed informed consent
Exclusion Criteria
- •Incomplete unilateral cleft lip infant
- •Association of other craniofacial anomalies
Outcomes
Primary Outcomes
The nasal morphology - Nostril height 1
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (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
Time Frame: (T1) at initial visit
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 2
Time Frame: (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
Time Frame: (T3) one week after surgery
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 4
Time Frame: (T4) 6 months after surgery
Nostril area: the area presented by nostril aperture.
Secondary Outcomes
- 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))