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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 bet

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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
    • 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
    • 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
    • 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


    Original Secondary Outcome: Same as current

    Information By: Chang Gung Memorial Hospital

    Dates:
    Date Received: June 3, 2013
    Date Started: May 2010
    Date Completion: July 2013
    Last Updated: June 19, 2013
    Last Verified: April 2013