Unilateral Complete Cleft Lip Clinical Trial
— NAMOfficial title:
Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
| Verified date | April 2013 |
| Source | Chang Gung Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 30 |
| Est. completion date | July 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 3 Months |
| Eligibility |
Inclusion Criteria: - Complete unilateral cleft lip infant - Signed informed consent Exclusion Criteria: - Incomplete unilateral cleft lip infant - Association of other craniofacial anomalies |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chun-Shin, Chang | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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) | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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) | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | The nasal morphology - nostril area 1 | Nostril area: the area presented by nostril aperture. | (T1) at initial visit | No |
| Primary | 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) | No |
| Primary | The nasal morphology - nostril area 3 | Nostril area: the area presented by nostril aperture. | (T3) one week after surgery | No |
| Primary | The nasal morphology - nostril area 4 | Nostril area: the area presented by nostril aperture. | (T4) 6 months after surgery | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |