Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Designed Passive Plate Therapy
Other interventionA 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: AI-Designed Passive Plate TherapyExperimental treatment 1 intervention
Group B: No Presurgical TherapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Percent Reduction in Cleft Width from Birth to Primary Surgery
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.
Time frame
From birth to time of primary cleft surgery (approximately 4 months of age)Secondary outcomes
1
Cleft Width at Time of Primary Surgery
Absolute cleft width (in mm) at the time of primary surgery, measured from intraoral scan data. This will be compared between infants who received AI-designed passive plates and those who received no presurgical therapy.
Time frame
At the time of primary cleft surgery (approximately 4 months of age)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
University of Basel
Collaborator
Source ClinicalTrials.gov