Clinical trial NCT01883726: Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
Official title: Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unilateral Complete Cleft Lip
Keywords: Unilateral complete cleft lip, Nasoalveolar molding
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Complete unilateral cleft lip infant
* Signed informed consent

Exclusion Criteria:

* Incomplete unilateral cleft lip infant
* Association of other craniofacial anomalies

Primary outcomes:
measure: The nasal morphology - Nostril height 1
timeFrame: (T1) at initial visit
measure: The nasal morphology - Nostril height 2
timeFrame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
measure: The nasal morphology - - Nostril height 3
timeFrame: (T3) one week after surgery
measure: The nasal morphology - Nostril height 4
timeFrame: (T4) 6 months after surgery
measure: The nasal morphology - Nostril width 1
timeFrame: (T1) at initial visit
measure: The nasal morphology - Nostril width 2
timeFrame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
measure: The nasal morphology - Nostril width 3
timeFrame: (T3) one week after surgery
measure: The nasal morphology - Nostril width 4
timeFrame: (T4) 6 months after surgery
measure: The nasal morphology - Nasal sill height 3
timeFrame: (T3) one week after surgery
measure: The nasal morphology - Nasal sill height 4
timeFrame: (T4) 6 months after surgery
measure: The nasal morphology - nostril area 1
timeFrame: (T1) at initial visit
measure: The nasal morphology - nostril area 2
timeFrame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
measure: The nasal morphology - nostril area 3
timeFrame: (T3) one week after surgery
measure: The nasal morphology - nostril area 4
timeFrame: (T4) 6 months after surgery
Secondary outcomes:
measure: duration of NAM
timeFrame: 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)
measure: total number of visits before surgical correction
timeFrame: From the initial visit to the date of surgery (participants' surgery will be performed on 3-month of age)
measure: cost of treatment
timeFrame: From initial orthodontic visit to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
measure: NAM complications
timeFrame: From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chun-Shin, Chang
Study officials:
References:
citation: Chang CS, Wallace CG, Pai BC, Chiu YT, Hsieh YJ, Chen IJ, Liao YF, Liou EJ, Chen PK. Comparison of two nasoalveolar molding techniques in unilateral complete cleft lip patients: a randomized, prospective, single-blind trial to compare nasal outcomes. Plast Reconstr Surg. 2014 Aug;134(2):275-282. doi: 10.1097/PRS.0000000000000361.