Jaw Abnormalities3D-VIRTOGNCT02660021
Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery
An observational study of Jaw Abnormalities, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and face that are related to structure or growth malfunctioning, orthodontic problems, or co-morbidities associated with skeletal disfigurement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Jaw Abnormalities
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2010to Dec 2025
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consenting patients, eligible for orthognathic surgery, performed at the General Hospital Saint-John Bruges, from July 1st 2010 onwards.
Who may be able to join
- Patients of all ages
- Both female and male patients
- Patients should present themselves at the Department of Oral and Maxillofacial Surgery of the General Hospital Saint-John Bruges for orthognathic surgical treatment
- Patients receive standardized cone-beam computed tomography (CBCT) image acquisition (i-CAT, Imaging sciences international, inc, Hatfield, USA) according to the "triple" CBCT scan protocol
- Patients' orthognathic surgery should be prepared by a standardized setup of an augmented 3D virtual patient model in centric relation, with detailed occlusal and intercuspidation data using the "triple" voxel-based rigid registration protocol (Maxilim v2.2.2., Nobel Biocare c/o Medicim nv, Mechelen, Belgium)
- Patients' surgery should be prepared preoperatively through 3D virtual planning steps performed with the same software, by the same surgeon (GS)
- Patients should be operated by the same surgeon (GS)
Who cannot join
- All patients that do not fit in the abovementioned description
- Patients with posttraumatic deformity
- Patients with congenital deformity
- Patients with preprosthetic indication
Trial locations and contacts
1 site in 1 country.
Araceli Diez-Fraile, VMD PhD contact
Belgium1 site, 1 recruiting
- Recruiting
General Hospital Saint-John Bruges
Bruges
Araceli Diez-Fraile, VMD PhD, araceli.diez-fraile@azsintjan.be
Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS
About this study
Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and face that are related to structure or growth malfunctioning, orthodontic problems, or co-morbidities associated with skeletal disfigurement.
Imaging is crucial in the assessment and treatment planning of orthognathic surgery patients. Until recently, two-dimensional (2D) imaging, through cephalometry, was standard practice. However, it showed several limitations. The introduction of the cone-beam computed tomography (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift. Though widespread implementation in routine practice is not yet present. Our department is one of the pioneers in the world of 3D virtual treatment planning for orthognathic surgery. The "triple CBCT scan procedure" has been developed in-house and implemented already in 2009.
Read more
The investigators aim to develop a prospective database registering 3D treatment planning data of all consecutive patients eligible for orthognathic surgery, performed by Prof. Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and orthognathic surgery data are being collected during consecutive visits within the framework of routine practice.
Development of a database registering 3D virtual treatment planning data of orthognathic surgery, will provide more information about potential patient, virtual planning and surgical factors influencing postoperative accuracy of jaw correction, long-term stability of the jawbone, long-term condylar resorption, or soft tissue response. In general, it could provide answers on research questions that have been examined in prior studies on 2D-imaging, but can now be re-examined in case of 3D-imaging. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.
- Conditions
- Jaw Abnormalities
- Keywords
- three-dimensional virtual treatment planning, orthognathic surgery
- Medical subject headings
- Jaw Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of hard tissue, soft tissue and teeth transfer after 3D planning, as measured with CBCT
Measured: within 12 months postoperative
Secondary outcomes (5)
Prevalence of patients with an indication for orthognathic surgery
Measured: 6 years
Accuracy of bone transfer, as measured through superimposition of 3D planning CBCT and postoperative CBCT
Measured: 4 weeks postoperative
Long-term stability, through clinical evaluation and superimposition of 3D planning CBCT and postoperative CBCT
Measured: 6 months postoperative
number of patients with condylar resorption
Measured: until 12 months postoperative
number of patients with temporomandibular joint complications
Measured: until 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJul 2010
- 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 Jaw AbnormalitiesStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwen Swennen, AZ Sint-Jan AV
- Investigators
- Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS, Principal investigator, Maxillofacial Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660021
- Sponsor's protocol ID
- B049201627035
- Acronym
- 3D-VIRTOG
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2016
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT02660021
- Acronym / sponsor ID
- 3D-VIRTOG / B049201627035
- Conditions
- Jaw Abnormalities
- Keywords
- three-dimensional virtual treatment planning, orthognathic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Jan 2016 (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.
Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and face that are related to structure or growth malfunctioning, orthodontic problems, or co-morbidities associated with skeletal disfigurement.
Imaging is crucial in the assessment and treatment planning of orthognathic surgery patients. Until recently, two-dimensional (2D) imaging, through cephalometry, was standard practice. However, it showed several limitations. The introduction of the cone-beam computed tomography (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift. Though widespread implementation in routine practice is not yet present. Our department is one of the pioneers in the world of 3D virtual treatment planning for orthognathic surgery. The "triple CBCT scan procedure" has been developed in-house and implemented already in 2009.
The investigators aim to develop a prospective database registering 3D treatment planning data of all consecutive patients eligible for orthognathic surgery, performed by Prof. Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and orthognathic surgery data are being collected during consecutive visits within the framework of routine practice.
Development of a database registering 3D virtual treatment planning data of orthognathic surgery, will provide more information about potential patient, virtual planning and surgical factors influencing postoperative accuracy of jaw correction, long-term stability of the jawbone, long-term condylar resorption, or soft tissue response. In general, it could provide answers on research questions that have been examined in prior studies on 2D-imaging, but can now be re-examined in case of 3D-imaging. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consenting patients, eligible for orthognathic surgery, performed at the General Hospital Saint-John Bruges, from July 1st 2010 onwards.
Key inclusion criteria (7 listed)
- Patients of all ages
- Both female and male patients
- Patients should present themselves at the Department of Oral and Maxillofacial Surgery of the General Hospital Saint-John Bruges for orthognathic surgical treatment
- Patients receive standardized cone-beam computed tomography (CBCT) image acquisition (i-CAT, Imaging sciences international, inc, Hatfield, USA) according to the "triple" CBCT scan protocol
- Patients' orthognathic surgery should be prepared by a standardized setup of an augmented 3D virtual patient model in centric relation, with detailed occlusal and intercuspidation data using the "triple" voxel-based rigid registration protocol (Maxilim v2.2.2., Nobel Biocare c/o Medicim nv, Mechelen, Belgium)
Key exclusion criteria (4 listed)
- All patients that do not fit in the abovementioned description
- Patients with posttraumatic deformity
- Patients with congenital deformity
- Patients with preprosthetic indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of hard tissue, soft tissue and teeth transfer after 3D planning, as measured with CBCT
Time frame: within 12 months postoperative
5 secondary outcomes
Prevalence of patients with an indication for orthognathic surgery
Time frame: 6 years
Accuracy of bone transfer, as measured through superimposition of 3D planning CBCT and postoperative CBCT
Time frame: 4 weeks postoperative
Long-term stability, through clinical evaluation and superimposition of 3D planning CBCT and postoperative CBCT
Time frame: 6 months postoperative
number of patients with condylar resorption
Time frame: until 12 months postoperative
number of patients with temporomandibular joint complications
Time frame: until 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
Araceli Diez-Fraile, VMD PhD contact
Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS principal investigator
Maxillofacial Surgeon
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 Jaw Abnormalities, run by AZ Sint-Jan AV 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 7 inclusion and 4 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 19 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Araceli Diez-Fraile, VMD PhD (araceli.diez-fraile@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of hard tissue, soft tissue and teeth transfer after 3D planning, as measured with CBCT (time frame: within 12 months postoperative). 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 19 Jan 2021.