Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate

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

NCT Number	NCT06970158
Lead Sponsor	University Hospital, Basel, Switzerland Collaborators: University of Basel
Conditions	Congenital Disorder, Cleft Lip Palate
Enrollment	70 participants
Start Date	2023-08-01
Primary Completion	2025-08-01 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-16