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

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ClinicalTrials.gov Identifier: NCT01883726
Recruitment Status : Unknown
Verified April 2013 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Unilateral Complete Cleft Lip Device: Grayson's presurgical nasoalveolar molding Device: Figueroa's presurgical nasoalveolar molding Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The nasal morphology - Nostril height 1 [ Time Frame: (T1) at initial visit ]
    Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.

  2. The nasal morphology - Nostril height 2 [ Time Frame: (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.

  3. The nasal morphology - - Nostril height 3 [ Time Frame: (T3) one week after surgery ]
    Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.

  4. The nasal morphology - Nostril height 4 [ Time Frame: (T4) 6 months after surgery ]
    Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.

  5. The nasal morphology - Nostril width 1 [ Time Frame: (T1) at initial visit ]
    Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.

  6. The nasal morphology - Nostril width 2 [ Time Frame: (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.

  7. The nasal morphology - Nostril width 3 [ Time Frame: (T3) one week after surgery ]
    Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.

  8. The nasal morphology - Nostril width 4 [ Time Frame: (T4) 6 months after surgery ]
    Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.

  9. The nasal morphology - Nasal sill height 3 [ Time Frame: (T3) one week after surgery ]
    Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.

  10. The nasal morphology - Nasal sill height 4 [ Time Frame: (T4) 6 months after surgery ]
    Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.

  11. The nasal morphology - nostril area 1 [ Time Frame: (T1) at initial visit ]
    Nostril area: the area presented by nostril aperture.

  12. The nasal morphology - nostril area 2 [ Time Frame: (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.

  13. The nasal morphology - nostril area 3 [ Time Frame: (T3) one week after surgery ]
    Nostril area: the area presented by nostril aperture.

  14. The nasal morphology - nostril area 4 [ Time Frame: (T4) 6 months after surgery ]
    Nostril area: the area presented by nostril aperture.


Secondary Outcome Measures :
  1. duration of NAM [ 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) ]
    Duration of NAM = Operation date - NAM initiation date

  2. total number of visits before surgical correction [ Time Frame: 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

  3. cost of treatment [ 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) ]
    Cost = cost of each visit of orthodontic and adjustment of NAM before surgery

  4. NAM complications [ 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) ]
    Any complication like mucosa ulceration and facial skin irritation



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete unilateral cleft lip infant
  • Signed informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883726


Locations
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Taiwan
Chun-Shin, Chang
Taipei, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01883726    
Other Study ID Numbers: 102-1267C
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: April 2013
Keywords provided by Chang Gung Memorial Hospital:
Unilateral complete cleft lip, Nasoalveolar molding
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities