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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
CompletedFirst Submitted
Initial submission to the registry
June 13, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedJune 22, 2026
June 1, 2026
2 years
June 13, 2026
June 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Nose and lip esthetics
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.
3 months
Study Arms (1)
Full Digitial NAM
EXPERIMENTALInfants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Infants with cleft lip and palate.
You may not qualify if:
- Syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry-Cairo University
Cairo, Giza Governorate, 00202, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 13, 2026
First Posted
June 22, 2026
Study Start
June 1, 2024
Primary Completion
May 30, 2026
Study Completion
May 30, 2026
Last Updated
June 22, 2026
Record last verified: 2026-06