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

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry-Cairo University

Cairo, Giza Governorate, 00202, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Infants with cleft lip and palate.

Exclusion criteria

Syndromes

Treatment and study plan

F-D-NAM

Device

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.

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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jun 22, 2026
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed