Using AI to design passive plates for newborns with cleft lip and palate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness of AI-designed passive plate therapy in reducing cleft size in newborns with unilateral cleft lip and palate. Infants will undergo intraoral scans at birth and again at around 4 months of age to compare cleft size between those receiving the therapy and those who do not. The study aims to determine if the AI-designed plates can lead to better surgical outcomes by minimizing cleft width before surgery. Conducted in India, the study leverages advancements in digital workflows and 3D printing to provide a potentially safer and more accessible treatment option.

Why it matters

Who can join: the full rules

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

Where it's running

• Saveetha Medical College
  Chennai, India Recruiting
• GSR Hospital Hyderabad
  Hyderabad, India Recruiting

Study contacts

• Principal investigator: Prasad Nalabothu, MDS PhD — University Hospital, Basel, Switzerland
• Study coordinator: Prasad Nalabothu, PhD
• Email: p.nalabothu@usb.ch
• Phone: +41765014420

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.