Unilateral Complete Cleft Lip
Conditions
Keywords
Unilateral complete cleft lip, Nasoalveolar molding
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.
Interventions
DEVICEGrayson's presurgical nasoalveolar molding
Grayson NAM
DEVICEFigueroa's presurgical nasoalveolar molding
Figueroa NAM
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 3 Months
Healthy volunteers
No
Inclusion criteria
* Complete unilateral cleft lip infant * Signed informed consent
Exclusion criteria
* Incomplete unilateral cleft lip infant * Association of other craniofacial anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The nasal morphology - nostril area 4 | (T4) 6 months after surgery | Nostril area: the area presented by nostril aperture. |
| The nasal morphology - Nasal sill height 4 | (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 | (T1) at initial visit | Nostril area: the area presented by nostril aperture. |
| The nasal morphology - nostril area 2 | (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 | (T3) one week after surgery | Nostril area: the area presented by nostril aperture. |
| The nasal morphology - Nostril width 3 | (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 | (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 | (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 - Nostril height 1 | (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 | (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 | (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 | (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 | (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 | (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Total number of orthodontic visit or NAM adjustment = number of adjustment of NAM |
| 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) | Cost = cost of each visit of orthodontic and adjustment of NAM before surgery |
| 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) | Any complication like mucosa ulceration and facial skin irritation |
| 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) | Duration of NAM = Operation date - NAM initiation date |
Countries
Taiwan
Outcome results
None listed