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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Percent Reduction in Cleft Width from Birth to Primary Surgery — From birth to time of primary cleft surgery (approximately 4 months of age)
  Measured as the percentage change in anterior-posterior cleft width between the intraoral scan at birth and the scan at the time of primary surgery (\~4 months), in infants receiving AI-designed passive plate therapy.

Trial sites (2)