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

RecruitingNAAges 1 Day - 6 MonthsAllUniversity Hospital, Basel, Switzerland
NCT06970158 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, depen

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📋 Eligibility rules (as published)
Inclusion criteria: Infants diagnosed with unilateral cleft lip and palate Age at enrollment: within the first 14 days of life (for treatment group) Age at cleft surgery: approximately 4 months Medically stable and fit to undergo intraoral scanning and cleft surgery Parent or legal guardian has provided written informed consent Exclusion Criteria: Syndromic cleft lip and palate or other craniofacial syndromes Bilateral cleft lip and palate Significant comorbidities affecting feeding, growth, or surgery (e.g., cardiac anomalies) Premature infants (\<37 weeks gestational age at birth) Infants who have already undergone any presurgical orthopedic intervention elsewhere Guardians/ Parents unwilling or unable to comply with follow-up or study procedures
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What it tests

  • AI-Designed Passive Plate Therapy
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Where

2 sites
Saveetha Medical College
Chennai, India
GSR Hospital Hyderabad
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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