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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07660042
Enrollment
14
Registered
2026-06-22
Start date
2024-06-01
Completion date
2026-05-30
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

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.

Interventions

DEVICEF-D-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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Months
Healthy volunteers
Yes

Inclusion criteria

* Infants with cleft lip and palate.

Exclusion criteria

* Syndromes

Design outcomes

Primary

MeasureTime frameDescription
Nose and lip esthetics3 monthsEvaluation 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026