Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient

Conditions
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Unilateral Complete Cleft Lip

Intervention / Treatment
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* Device: Grayson's presurgical nasoalveolar molding
* Device: Figueroa's presurgical nasoalveolar molding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete unilateral cleft lip infant Signed informed consent Exclusion Criteria: Incomplete unilateral cleft lip infant Association of other craniofacial anomalies

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grayson NAM<br>Intervention: Grayson nasoalveolar molding This technique uses an acrylic plate to mold the alveolar segments and uses an extension to mold the alar cartilage of the nasal component. The construction is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. When the alveolar gap is reduced to 5 mm, nasal component are added to gradually mold the nasal cartilage and other nasal structures. | Device: Grayson's presurgical nasoalveolar molding<br>* Grayson NAM<br>|
| Experimental: Figueroa NAM<br>Intervention: Figueroa's nasoalveolar molding Figueroa technique uses labial tapes and acrylic relief to the palatal plate to approximate alveolar gap [3]. The nasal component is added in the beginning of the treatment to mold the nasal cartilage. | Device: Figueroa's presurgical nasoalveolar molding<br>* Figueroa NAM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nasal morphology - Nostril height 1 | Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture. | (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. | (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. | (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. | (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. | (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. | (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. | (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. | (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. | (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. | (T4) 6 months after surgery | 
| The nasal morphology - nostril area 1 | Nostril area: the area presented by nostril aperture. | (T1) at initial visit | 
| The nasal morphology - nostril area 2 | Nostril area: the area presented by nostril aperture. | (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. | (T3) one week after surgery | 
| The nasal morphology - nostril area 4 | Nostril area: the area presented by nostril aperture. | (T4) 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of NAM | Duration of NAM = Operation date - NAM initiation date | 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 | 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 | 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 | From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral complete cleft lip, Nasoalveolar molding