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

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.

Study Overview

• Status: Unknown
• Conditions: Unilateral Complete Cleft Lip
• Intervention / Treatment: Device: Grayson's presurgical nasoalveolar molding; Device: Figueroa's presurgical nasoalveolar molding

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 333
    • Chun-Shin, Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Complete unilateral cleft lip infant
• Signed informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grayson NAM; 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; Grayson NAM
Experimental: Figueroa NAM; 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; Figueroa NAM

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Unilateral complete cleft lip, Nasoalveolar molding
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 102-1267C