Using AI to design passive plates for newborns with cleft lip and palate
Effect of Automated AI Designed Presurgical Plate Therapy on Cleft Size Reduction in Newborns With Cleft Lip and Palate : A Comparative Study
This study is testing if special plates designed by AI can help reduce the size of clefts in newborns with cleft lip and palate before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Day to 6 Months |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Chennai and 1 other locations) |
| Trial ID | NCT06970158 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants diagnosed with unilateral cleft lip and palate who are enrolled within the first 14 days of life.
Not a fit: Patients with syndromic cleft lip and palate, bilateral cleft lip and palate, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for infants with cleft lip and palate.
How similar studies have performed: While the use of AI in medical applications is growing, this specific approach to passive plate therapy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chennai and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.