Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.

Cleft Palate Clinical Trial

Official title:

Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342234
• Other study ID #: 2020-00388; ch19Mueller2
• Status: Recruiting
• Start date: March 5, 2020
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Benito Benitez, Dr. med. Dr. med. dent.
• Phone: +41 61 556 52 85
• Email: benito.benitez[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to develop a neural network to compute palatal three dimensional (3D) geometry by using routinely taken intraoral/palatal photographs and palatal casts of infants with cleft lip and palate deformity for reducing cleft lip and palate treatment burden. Data of palatal casts and palatal images of cleft patients routinely treated at the University Hospital Basel will be analyzed.The collection of large data helps in developing a neural network that will allow the computation of the 3D geometry from single photographs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with cleft lip and palate malformation with available routinely performed plaster cast model from palatal impressions, intraoral scans from the palate and corresponding images of the cleft palate (1970 till 2025)

Exclusion Criteria:

• Existence of a documented rejection

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate
• Orofacial Cleft

Intervention

Other:
• data collection of palatal casts and palatal images of cleft patients routinely treated at the institution
data collection of palatal casts and palatal images of cleft patients, using routinely taken intraoral/palatal photographs and palatal casts of infants with cleft lip and palate deformity

Locations

Country	Name	City	State
Switzerland	Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel	Basel

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Botnar Research Centre for Child Health (BRCCH), Department of Computer Science, Computer Graphics Laboratory, ETH Zurich, sciCORE Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D palatal geometry	palatal cleft photographs (input) and corresponding 3D palatal geometry (output) create this 3D palatal geometry for development of image based, non-invasive palatal shape reconstruction	at baseline