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Smartphone 3D Scanning to Create Special Plates for Babies with Cleft Lip and Palate to Improve Nose Shape, Reduce Cleft Gap, and Help with Feeding.

Digital design and 3D printing of presurgical plates using intraoral 3D image capturing. - Nill

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083377
Enrollment
20
Registered
2025-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q375- Cleft hard and soft palate with unilateral cleft lip

Interventions

Intervention1: Presurgical infant orthopedics Appliance: Nasoalveolar Molding treatment is initiated shortly after birth to reduce the cleft width and facilitate feeding. A digitally designed Presurgi

Sponsors

GSR Institute of Craniofacial Surgery Hyderabad
Lead Sponsor
University Hospital Basel
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: a. Infants with complete unilateral cleft lip and palate b. No syndromes c. Medically fit for treatment d. One parent/guardian a native language speaker e. Signed informed consent

Exclusion criteria

Exclusion criteria: a. Consent not obtained b. Bilateral, incomplete or submucous cleft c. Congenital hearing loss or structural middle ear anomalies d. A congenital heart defect

Design outcomes

Primary

MeasureTime frame
Improvement in Nasal MorphologyTimepoint: 6 months (base line to before Primary Cheiloplasty)—

Secondary

MeasureTime frame
Reduction of Alveolar Cleft WidthTimepoint: 6 months (base line to before Primary Cheiloplasty);Enhanced Neonatal Feeding EfficiencyTimepoint: 6 months (base line to before Primary Cheiloplasty);weight gainTimepoint: 6 months (base line to before Primary Cheiloplasty)—

Countries

India

Contacts

Public ContactDr Hemwati Nandan

GSR Institute of Craniofacial Surgery Hyderabad

hemwatinandanbahuguna@gmail.com09997703789

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026