Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
- Conditions
- Unilateral Complete Cleft Lip
- Interventions
- Device: Grayson's presurgical nasoalveolar moldingDevice: Figueroa's presurgical nasoalveolar molding
- Registration Number
- NCT01883726
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Complete unilateral cleft lip infant
- Signed informed consent
- Incomplete unilateral cleft lip infant
- Association of other craniofacial anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Grayson NAM Grayson's presurgical nasoalveolar molding 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. Figueroa NAM Figueroa's presurgical nasoalveolar molding 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.
- Primary Outcome Measures
Name Time Method 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 - 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.
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 - 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 - 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 area 4 (T4) 6 months after surgery Nostril area: the area presented by nostril aperture.
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Chun-Shin, Chang
🇨🇳Taipei, Taiwan