Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
Sponsor: University Hospital, Basel, Switzerland
Summary
The goal of this observational study is to evaluate whether passive plate therapy using automated AI-designed devices can reduce cleft size in newborns with cleft lip and palate. The main questions it aims to answer are: Does AI-designed passive plate therapy reduce the cleft size between birth and primary surgery? (Primary aim) How does cleft size at the time of surgery compare between infants who received passive plate therapy and those who did not? (Secondary aim) Researchers will compare infants who received AI-designed passive plate therapy with those who received no presurgical therapy to determine whether the intervention leads to a greater reduction in cleft width. Participants will: Undergo intraoral scans at birth and again at the time of primary surgery, around 4 months of age. Receive either no presurgical intervention or be treated with AI-designed passive plates, depending on site-specific clinical practices
Official title: Effect of Automated AI Designed Presurgical Plate Therapy on Cleft Size Reduction in Newborns With Cleft Lip and Palate : A Comparative Study
Key Details
Gender
All
Age Range
1 Day - 6 Months
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-08-01
Completion Date
2025-12-31
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
AI-Designed Passive Plate Therapy
A removable passive orthopedic plate designed using an AI-assisted digital workflow based on intraoral scan data. The design process is automated via a Blender-based software plugin that identifies anatomical landmarks and generates a custom-fit plate. The plate is 3D printed using biocompatible material and fitted shortly after birth. It is worn continuously until primary surgical repair, typically around 4 months of age. The intervention aims to reduce cleft width prior to surgery without requiring traditional impressions or extensive manual design effort.
Locations (2)
Saveetha Medical College
Chennai, India
GSR Hospital Hyderabad
Hyderabad, India