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

NCT04342234 | Recruiting

• 1 other identifier: 2020-00388; ch19Mueller2
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cleft Palate; Orofacial Cleft

Keywords

Cleft Lip; Neural Network; palatal plate therapy; palatal 3D geometry; palatal shape reconstruction

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

data collection of palatal casts and palatal images of cleft patients routinely treated at the institution OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cleft lip and palate malformation with available routinely performed plaster cast model from palatal impressions and/or intraoral scans of palate, and corresponding images of the cleft palate treated in the past as well as future patients treated at University hospital Basel (USB) for the last 50 years will be included (1970 till 2025). Models were (until 2020) and intraoral scans are (since 2020) taken routinely in newborns and for follow-up (age 1-20 years) according to WHO Guidelines.

You may qualify if:

• 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)

You may not qualify if:

• Existence of a documented rejection

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Botnar Research Centre for Child Health (BRCCH): collaborator
• sciCORE Basel: collaborator
• Department of Computer Science, Computer Graphics Laboratory, ETH Zurich: collaborator

Study Sites (1)

Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Study Officials

• Andreas Müller, PD Dr. med. Dr. med. dent. Dr.

  Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benito Benitez, Dr. med. Dr. med. dent.

CONTACT

+41 61 556 52 85; benito.benitez@usb.ch

Andreas Müller, PD Dr. med. Dr. med. dent. Dr.

CONTACT

+41 061 328 60 95; andreas.mueller@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: March 5, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CH (1)