Study of AI-Designed Presurgical Plate Therapy to Reduce Cleft Size in Newborns with Unilateral Cleft Lip and Palate

What this Trial Is About

This research investigates whether passive plate therapy designed using automated artificial intelligence AI can reduce cleft size in newborns with unilateral cleft lip and palate. The study compares infants receiving AI-designed passive plates to those receiving no presurgical therapy, aiming to assess cleft width reduction from birth to primary surgery around 4 months of age. The study is observational and non-randomized, enrolling infants from two clinical sites with differing standard practices. Infants in the therapy group will be fitted shortly after birth with a custom passive plate designed through an AI-driven digital workflow using intraoral scans. These plates are 3D printed and worn continuously until primary surgical repair. Infants in the comparison group will receive no presurgical orthopedic intervention. All participants undergo intraoral scans at birth andor surgery to measure cleft size. Participants will have intraoral scans shortly after birth and again at primary surgery to digitally measure cleft width and calculate reduction percentages. The study monitors cleft size change using validated 3D imaging techniques. Data from both groups will be statistically analyzed to compare anatomical outcomes. Participation involves routine procedures aligned with standard cleft treatment timelines, with no additional interventions or medications.

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