Clinical Trial: Efficiency of Novel Nasoalveolar Molding Method on Parents' Satisfaction in Unilateral Cleft Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficiency of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Pala

Brief Summary: The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

Detailed Summary: In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.
Sponsor: Cairo University

Current Primary Outcome: Parents' satisfaction [ Time Frame: 3 months ]

It will be assessed using Questionnaire.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Nasal Esthetics: a- Nostril height [ Time Frame: 3 months ]
    It will be measured in mm by Digital ruler on the images using a software.
  • Nasal Esthetics: b- Nostril width [ Time Frame: 3 months ]
    It will be measured in mm by Digital ruler on the images using a software.
  • Nasal Esthetics: c- Nasal sill height [ Time Frame: 3 months ]
    It will be measured in mm by Digital ruler on the images using a software.
  • Nasal Esthetics: d- Nostril area [ Time Frame: 3 months ]
    It will be measured on the images in mm 2 (square) using a software measuring area.
  • Interlabial gap [ Time Frame: 3 months ]
    It will be measured in mm by Digital ruler on the images using a software.
  • Maxillary Arch Dimension [ Time Frame: 3 months ]
    It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes.


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: July 19, 2016
Date Started: November 2016
Date Completion: January 2018
Last Updated: April 10, 2017
Last Verified: April 2017