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RecruitingNCT04342234Updated Mar 24, 2025

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

An observational study in Cleft Palate and Orofacial Cleft, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Sex
All
01

Study 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.

02

Conditions studied

  • Cleft Palate
  • Orofacial Cleft

Keywords

  • Cleft Lip
  • Neural Network
  • palatal plate therapy
  • palatal 3D geometry
  • palatal shape reconstruction
03

In context

Cleft Palate

123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.

This study's planned enrollment of 450 is above the median of 85 across 40 observational studies indexed under Cleft Palate.

Browse Cleft Palate studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Browse University Hospital, Basel, Switzerland studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Existence of a documented rejection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No

Interventions

  • Otherdata 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

06

What researchers measure

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

    Time frame: at baseline

07

Study locations

1 of 1 sites recruiting
  • Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel
    Basel, 4031, Switzerland
    Recruiting
    • Benito Benitez, Dr. med. Dr. med. dent. · Contactbenito.benitez@usb.ch · +41 61 556 52 85
    • Andreas Müller, PD Dr. med. Dr. med. dent. · Contactandreas.mueller@usb.ch · +41 061 328 60 95
    • Martin Erismann · Sub investigator
    • Prasad Nalabothu, Dr. · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Dec 2025, 69 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2020
First posted
Apr 10, 2020
StartActual
Mar 5, 2020
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Mar 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04342234
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Botnar Research Centre for Child Health (BRCCH), sciCORE Basel, Department of Computer Science, Computer Graphics Laboratory, ETH Zurich
Responsible party
Sponsor
First posted
Apr 10, 2020
Start date
Mar 5, 2020
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Mar 24, 2025

Study contacts

Benito Benitez, Dr. med. Dr. med. dent.
Contact
benito.benitez@usb.ch
+41 61 556 52 85
Andreas Müller, PD Dr. med. Dr. med. dent. Dr.
Contact
andreas.mueller@usb.ch
+41 061 328 60 95
Andreas Müller, PD Dr. med. Dr. med. dent. Dr.
principal investigator · Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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