Actively Recruiting
Led by University Hospital, Basel, Switzerland · Updated on 2025-05-16
70
Participants Needed
2
Research Sites
21 weeks
Total Duration
U
University Hospital, Basel, Switzerland
Lead Sponsor
U
University of Basel
Collaborating Sponsor
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 and/or 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.
CONDITIONS
Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
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Duration - Within the first 2 weeks of life
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for enrollment and baseline intraoral scan
Duration - Approximately 4 months until primary surgery
Participants in the intervention group wear an AI-designed passive plate continuously from shortly after birth until their primary cleft surgery. The plate is custom designed using intraoral scans and 3D printing to reduce cleft size prior to surgery.
Continuous use of the passive plate with regular clinical monitoring visits as per routine care
Duration - Approximately 4 months until primary surgery
Participants in the no presurgical therapy group do not receive any passive plate intervention. They continue with routine care until primary surgery.
Routine clinical follow-up visits as per standard care
Duration - 1 day
Participants undergo primary cleft lip and palate surgical repair around 4 months of age. Intraoral scans are performed again at this time to assess cleft width.
1 visit (in-person) for surgery and intraoral scan
Total: 2 locations
1
Saveetha Medical College
Chennai, India, 602105
Actively Recruiting
2
GSR Hospital Hyderabad
Hyderabad, India, 500059
Actively Recruiting
P
Prasad Nalabothu, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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