Clinical Trial: Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

Brief Summary: Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.

Detailed Summary:
Sponsor: Cairo University

Current Primary Outcome: Alveolar alignment [ Time Frame: 5-6 months ]

Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments


Original Primary Outcome: Parents' satisfaction [ Time Frame: Three months ]

Questionnaire


Current Secondary Outcome: Nasal and labial esthetics [ Time Frame: 5-6 months ]

Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap


Original Secondary Outcome:

  • Short term esthetic outcomes (nasal and interlabial gap) [ Time Frame: Three months ]
    Reference points, lines and planes on standardized photos recording the symmetry of nostrils and interlabial gap
  • short term maxillary arch alignment [ Time Frame: Three months ]
    Reference points lines and planes on digital models recording the symmetry and alignment of maxillary arch


Information By: Cairo University

Dates:
Date Received: August 24, 2016
Date Started: December 2016
Date Completion: December 2018
Last Updated: November 14, 2016
Last Verified: November 2016