Mandibular DiseasesNCT04475237
Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
An observational study of Mandibular Diseases and SSM, run by CADskills at 1 site in Belgium.
Trial summary
Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Diseases, SSM
- What is being tested?
- CT-scan evaluation and segmentation
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 5 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: European adults
Who may be able to join
- Healthy mandibles
Who cannot join
- Mandibles with major deformities
- Mandibles with obvious problems
- Mandibles that already underwent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone.
Read the detailed description
Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be selected from the database (50 males and 50 females, between 20 and 60 years old). First, they will be anonymized (except the sex and age/date of birth). Afterwards, they will be segmented using Materialise Mimics software. The segmented mandibles will then be used to create a statistical shape model (SSM) using principal component analysis. This model will afterwards be used to predict the mandibular shapes.
- Conditions
- Mandibular Diseases, SSM
- Being tested
- CT-scan evaluation and segmentation
- Medical subject headings
- Mandibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scan evaluation and segmentationOther
CT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted.
| Study group | Role | What they receive |
|---|---|---|
| Healthy mandibles | Belgian adults (between 20 and 60 years old), 50/50 male/female, with no major mandibular problems/deformities Receives: Other: CT-scan evaluation and segmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A statistical shape model of a mandible
A statistical shape model of a mandible
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jan 2020
- Primary completion1 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular DiseasesStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CADskills
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475237
- Sponsor's protocol ID
- SSM
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
- ClinicalTrials.gov ID
- NCT04475237
- Acronym / sponsor ID
- SSM
- Conditions
- Mandibular Diseases, SSM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CADskillsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 17 Jul 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.
Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone.
Detailed description
Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be selected from the database (50 males and 50 females, between 20 and 60 years old). First, they will be anonymized (except the sex and age/date of birth). Afterwards, they will be segmented using Materialise Mimics software. The segmented mandibles will then be used to create a statistical shape model (SSM) using principal component analysis. This model will afterwards be used to predict the mandibular shapes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy mandibles | – | Other: CT-scan evaluation and segmentationBelgian adults (between 20 and 60 years old), 50/50 male/female, with no major mandibular problems/deformities |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- European adults
Key inclusion criteria (1 listed)
- Healthy mandibles
Key exclusion criteria (3 listed)
- Mandibles with major deformities
- Mandibles with obvious problems
- Mandibles that already underwent surgery
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 |
|---|---|---|
| CT-scan evaluation and segmentationCT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted. | Other | Healthy mandibles |
Primary outcome
A statistical shape model of a mandible
Time frame: 2 months
A statistical shape model of a mandible
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Mandibular Diseases and SSM, run by CADskills at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 3 Aug 2021. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A statistical shape model of a mandible (time frame: 2 months). 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 3 Aug 2021.