Evaluation of Efficiency the Full Digital Nasoalveolar Molding (F-D-NAM) on Nose and Lip Esthetics and Maxillary Arch Changes in Infants With Cleft Lip and Palate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Nose and lip esthetics
Study Overview
Brief Summary
Objectives: The aim of this study is to validate the measurements produced from a new 3D analysis using facial scans in infants with unilateral cleft lip and palate.
Material and Methods: Infants with unilateral cleft lip and palate will be included in the current study. For all included patients; direct anthropometric measurements, 2D images and facial scans using intraoral scanners will be collected. Measurements produced from the 3 methods will be compared statistically to identify the validity of using the facial scans to assess nasolabial esthetics in infants with unilateral cleft lip and palate.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 2 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Infants with cleft lip and palate.
Exclusion Criteria
- •Syndromes
Arms & Interventions
Full Digitial NAM
Infants with unilateral cleft lip and palate will be included in the current study. For all included patients; direct anthropometric measurements, 2D images and facial scans using intraoral scanners will be collected. Measurements produced from the 3 methods will be compared statistically to identify the validity of using the facial scans to assess nasolabial esthetics in infants with unilateral cleft lip and palate.
Intervention: F-D-NAM (Device)
Outcomes
Primary Outcomes
Nose and lip esthetics
Time Frame: 3 months
Evaluation of nose and lip esthetics on facial scans and photos. Clefted nostril width and height, interlabial gap and columellar length will be assessed digitally on facial scans and 2D photographs in millimeters.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Abd El-Ghafour
Associate Professor
Cairo University