Cleft PalateNCT04342234
Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.
An observational study of Cleft Palate and Orofacial Cleft, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Palate, Orofacial Cleft
- What is being tested?
- data collection of palatal casts and palatal images of cleft patients routinely treated at the institution
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Mar 2020to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Existence of a documented rejection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel
Basel, 4031
Benito Benitez, Dr. med. Dr. med. dent., +41 61 556 52 85, benito.benitez@usb.ch
Andreas Müller, PD Dr. med. Dr. med. dent., +41 061 328 60 95, andreas.mueller@usb.ch
About this study
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
- Being tested
- data collection of palatal casts and palatal images of cleft patients routinely treated at the institution
- Keywords
- Cleft Lip, Neural Network, palatal plate therapy, palatal 3D geometry, palatal shape reconstruction
- Medical subject headings
- Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection of palatal casts and palatal images of cleft patients routinely treated at the institutionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start5 Mar 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Botnar Research Centre for Child Health (BRCCH), sciCORE Basel, Department of Computer Science, Computer Graphics Laboratory, ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Andreas Müller, PD Dr. med. Dr. med. dent. Dr., Principal investigator, Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342234
- Sponsor's protocol ID
- 2020-00388; ch19Mueller2
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2020
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.
- ClinicalTrials.gov ID
- NCT04342234
- Acronym / sponsor ID
- 2020-00388; ch19Mueller2
- Conditions
- Cleft Palate, Orofacial Cleft
- Keywords
- Cleft Lip, Neural Network, palatal plate therapy, palatal 3D geometry, palatal shape reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Botnar Research Centre for Child Health (BRCCH), sciCORE Basel, Department of Computer Science, Computer Graphics Laboratory, ETH Zurich
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Existence of a documented rejection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection of palatal casts and palatal images of cleft patients routinely treated at the institutiondata 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 | Other | – |
Primary outcome
3D palatal geometry
Time frame: at baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Müller, PD Dr. med. Dr. med. dent. Dr. principal investigator
Mund-, Kiefer- und Gesichtschirurgie, Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate and Orofacial Cleft, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benito Benitez, Dr. med. Dr. med. dent. (+41 61 556 52 85, benito.benitez@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D palatal geometry (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.