search
Back to results

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

Primary Purpose

Unilateral Complete Cleft Lip

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Grayson's presurgical nasoalveolar molding
Figueroa's presurgical nasoalveolar molding
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Complete Cleft Lip focused on measuring Unilateral complete cleft lip, Nasoalveolar molding

Eligibility Criteria

1 Week - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complete unilateral cleft lip infant
  • Signed informed consent

Exclusion Criteria:

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

Sites / Locations

  • Chun-Shin, Chang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Grayson NAM

Figueroa NAM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The nasal morphology - Nostril height 1
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril height 2
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - - Nostril height 3
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril height 4
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril width 1
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 2
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 3
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 4
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
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.
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.
The nasal morphology - nostril area 1
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 2
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 3
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 4
Nostril area: the area presented by nostril aperture.

Secondary Outcome Measures

duration of NAM
Duration of NAM = Operation date - NAM initiation date
total number of visits before surgical correction
Total number of orthodontic visit or NAM adjustment = number of adjustment of NAM
cost of treatment
Cost = cost of each visit of orthodontic and adjustment of NAM before surgery
NAM complications
Any complication like mucosa ulceration and facial skin irritation

Full Information

First Posted
June 3, 2013
Last Updated
June 19, 2013
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01883726
Brief Title
Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
Acronym
NAM
Official Title
Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Complete Cleft Lip
Keywords
Unilateral complete cleft lip, Nasoalveolar molding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grayson NAM
Arm Type
Experimental
Arm Description
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.
Arm Title
Figueroa NAM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Grayson's presurgical nasoalveolar molding
Intervention Description
Grayson NAM
Intervention Type
Device
Intervention Name(s)
Figueroa's presurgical nasoalveolar molding
Intervention Description
Figueroa NAM
Primary Outcome Measure Information:
Title
The nasal morphology - Nostril height 1
Description
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time Frame
(T1) at initial visit
Title
The nasal morphology - Nostril height 2
Description
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time Frame
(T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Title
The nasal morphology - - Nostril height 3
Description
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time Frame
(T3) one week after surgery
Title
The nasal morphology - Nostril height 4
Description
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Time Frame
(T4) 6 months after surgery
Title
The nasal morphology - Nostril width 1
Description
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time Frame
(T1) at initial visit
Title
The nasal morphology - Nostril width 2
Description
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time Frame
(T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Title
The nasal morphology - Nostril width 3
Description
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time Frame
(T3) one week after surgery
Title
The nasal morphology - Nostril width 4
Description
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Time Frame
(T4) 6 months after surgery
Title
The nasal morphology - Nasal sill height 3
Description
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
Time Frame
(T3) one week after surgery
Title
The nasal morphology - Nasal sill height 4
Description
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
Time Frame
(T4) 6 months after surgery
Title
The nasal morphology - nostril area 1
Description
Nostril area: the area presented by nostril aperture.
Time Frame
(T1) at initial visit
Title
The nasal morphology - nostril area 2
Description
Nostril area: the area presented by nostril aperture.
Time Frame
(T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Title
The nasal morphology - nostril area 3
Description
Nostril area: the area presented by nostril aperture.
Time Frame
(T3) one week after surgery
Title
The nasal morphology - nostril area 4
Description
Nostril area: the area presented by nostril aperture.
Time Frame
(T4) 6 months after surgery
Secondary Outcome Measure Information:
Title
duration of NAM
Description
Duration of NAM = Operation date - NAM initiation date
Time Frame
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)
Title
total number of visits before surgical correction
Description
Total number of orthodontic visit or NAM adjustment = number of adjustment of NAM
Time Frame
From the initial visit to the date of surgery (participants' surgery will be performed on 3-month of age)
Title
cost of treatment
Description
Cost = cost of each visit of orthodontic and adjustment of NAM before surgery
Time Frame
From initial orthodontic visit to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Title
NAM complications
Description
Any complication like mucosa ulceration and facial skin irritation
Time Frame
From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete unilateral cleft lip infant Signed informed consent Exclusion Criteria: Incomplete unilateral cleft lip infant Association of other craniofacial anomalies
Facility Information:
Facility Name
Chun-Shin, Chang
City
Taipei
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24732649
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs