MalocclusionACRO3DNCT01413373
3D Craniofacial Cephalometric Analysis
An observational study of Malocclusion, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- cone beam computed tomography and computer tomography
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2008to Dec 2020
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient more than 18 yeras old, no pregnant women, no child
Who may be able to join
- maxillomandibular dysmorphoses,
- facial asymmetry,
- craniofacial syndromes
Who cannot join
- patients with orthodontic treatment only
- growing patients
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of oral and maxillofacial surgery, Cliniques universitaires saint Luc
Brussels, 1200
Raphael Olszewski, DDS,MD,PhD, 003227645718, raphael.olszewski@uclouvain.be
Raphael Olszewski, MD,PhD
About this study
Official title: Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis
Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.
Read the detailed description
Cone beam computed tomography is taken for diagnosis independently from this study. Investigators are using this medical imaging for performing the 3D cephalometric analysis. Investigators apply a set of well described landmarks of three-dimensional reconstruction of the skull from patients suffering from diverse craniofacial malformations. Then a set of specific measurements is taken from the patient and provide insights how to modify the anatomy of the patient to improve the skull's architecture and symmetry
- Conditions
- Malocclusion
- Being tested
- cone beam computed tomography, computer tomography
- Keywords
- cephalometry, three-dimensional, CT scan, lateral radiography, facial symmetry, maxillomandibular dysmorphoses
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone beam computed tomographyRadiation
Also called medical imaging, CBCT
A preoperative CBCT is performed for all patients in this study for medical reason
computer tomographyRadiation
Also called medical imaging
One cone beam computer tomography examination before surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
topological description of maxillomandibular dysmorphosis (angles, distances)
Anterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Posterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Ratio between distance from nasion to anterior nasal spine/anterior nasal spine to chin landmark (without unit of maesurment) Measurements between various anatomic landmarks for orbits and maxillary sinus structures on the three-dimensional CT reconstruction of the patient's skull (in mm).
Measured: 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2008
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael Olszewski, DDS,MD,PhD, Principal investigator, Department of Oral and maxillofacial surgery, Cliniques Universitaires saint Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413373
- Sponsor's protocol ID
- B40320083938
- Other IDs
- 2014/13MAR/104, MAXILLARY SEPTA 3D
- Acronym
- ACRO3D
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2011
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis
- ClinicalTrials.gov ID
- NCT01413373
- Acronym / sponsor ID
- ACRO3D / B40320083938
- Conditions
- Malocclusion
- Keywords
- cephalometry, three-dimensional, CT scan, lateral radiography, facial symmetry, maxillomandibular dysmorphoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Aug 2011 (estimated)
- 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.
Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.
Detailed description
Cone beam computed tomography is taken for diagnosis independently from this study. Investigators are using this medical imaging for performing the 3D cephalometric analysis. Investigators apply a set of well described landmarks of three-dimensional reconstruction of the skull from patients suffering from diverse craniofacial malformations. Then a set of specific measurements is taken from the patient and provide insights how to modify the anatomy of the patient to improve the skull's architecture and symmetry
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient more than 18 yeras old, no pregnant women, no child
Key inclusion criteria (3 listed)
- maxillomandibular dysmorphoses,
- facial asymmetry,
- craniofacial syndromes
Key exclusion criteria (2 listed)
- patients with orthodontic treatment only
- growing patients
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 |
|---|---|---|
| cone beam computed tomographyAlso: medical imaging, CBCTA preoperative CBCT is performed for all patients in this study for medical reason | Radiation | – |
| computer tomographyAlso: medical imagingOne cone beam computer tomography examination before surgery | Radiation | – |
Primary outcome
topological description of maxillomandibular dysmorphosis (angles, distances)
Time frame: 2014
Anterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Posterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Ratio between distance from nasion to anterior nasal spine/anterior nasal spine to chin landmark (without unit of maesurment) Measurements between various anatomic landmarks for orbits and maxillary sinus structures on the three-dimensional CT reconstruction of the patient's skull (in mm).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Malocclusion
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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.
Raphael Olszewski, DDS,MD,PhD principal investigator
Department of Oral and maxillofacial surgery, Cliniques Universitaires saint Luc
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 Malocclusion, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rapahel Olszewski, DDS,MD,PhD (003227645718 ext. 5718, raphael.olszewski@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
topological description of maxillomandibular dysmorphosis (angles, distances) (time frame: 2014). 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 15 Jul 2019.