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

NCT06970158 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-16

No results posted yet for this 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

Conditions

  • Congenital Disorder
  • Cleft Lip Palate

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Andreas Mueller, PhD,MHBA · University Hospital, Basel, Switzerland

  • Prasad Nalabothu, MDS PhD · University Hospital, Basel, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-08-01
Completion
2025-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970158 on ClinicalTrials.gov