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 ]
Original Primary Outcome: Parents' satisfaction [ Time Frame: Three months ]
Current Secondary Outcome: Nasal and labial esthetics [ Time Frame: 5-6 months ]
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