Craniofacial AbnormalitiesNCT00285714
3D Imaging of Hard and Soft Tissue in Orthognathic Surgery
A study testing 3D stereophotogrammetric imaging, 3D CT-imaging with cone-beam CT and Case report form in people with Craniofacial Abnormalities and Maxillofacial Abnormalities, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Craniofacial Abnormalities, Maxillofacial Abnormalities, Cleft Lip
- What is being tested?
- 3D stereophotogrammetric imaging, 3D CT-imaging with cone-beam CT and Case report form
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2006to Dec 2010
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dysgnathic deformity
- Caucasian
- > 15 years
- No history of orthognathic surgery
- Informed Consent
Who cannot join
- < 15 years
- History of Orthognathic surgery
- Not Caucasian
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Rijnstate Hospital
Arnhem, 6815 AD
Th.J.M. Hoppenreijs, Dr., +31-26-3787434
Th.J.M. Hoppenreijs, MD, DMD, PhD
- Recruiting
Hospital Gelderse Vallei
Ede, 6716 RP
P.J. Van Strijen, Dr., +31-318-435140
P.J. Van Strijen, MD, DMD, PhD
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
Joanneke Plooij, MD, +31-24-3619464, j.plooij@mka.umcn.nl
Joanneke Plooij, MD
About this study
Official title: An Analysis of the Clinical Applicability of a Three-Dimensional Imaging Platform Used to Register the Influence of Orthognathic Surgery on Facial Hard and Soft Tissue in Patients With Congenital Maxillofacial Deformities.
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.
- Being tested
- 3D stereophotogrammetric imaging, 3D CT-imaging with cone-beam CT, Case report form
- Keywords
- 3D computer assisted imaging, maxillofacial surgery, cephalometry, normative value
- Medical subject headings
- Craniofacial Abnormalities, Maxillofacial Abnormalities, Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D stereophotogrammetric imagingProcedure or surgery
3D CT-imaging with cone-beam CTProcedure or surgery
Case report formProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.
Secondary outcomes (3)
All postoperative changes in functionality at 1 year
patients' satisfaction of facial proportions at 1 year
surgeons' satisfaction of the 3D planning platform at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Stefaan J Bergé, Prof, MD, DMD, PhD,, Study director, Radboud University Medical CenterFilip AC Schutyser, MsC, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285714
- Sponsor's protocol ID
- 3D_MKC590_JP01
- Status last verified
- Jul 2007
- First submitted
- 1 Feb 2006
- Last updated
- 27 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Clinical Applicability of a Three-Dimensional Imaging Platform Used to Register the Influence of Orthognathic Surgery on Facial Hard and Soft Tissue in Patients With Congenital Maxillofacial Deformities.
- ClinicalTrials.gov ID
- NCT00285714
- Acronym / sponsor ID
- 3D_MKC590_JP01
- Keywords
- 3D computer assisted imaging, maxillofacial surgery, cephalometry, normative value
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Feb 2006 (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.
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Dysgnathic deformity
- Caucasian
- > 15 years
- No history of orthognathic surgery
- Informed Consent
Key exclusion criteria (3 listed)
- < 15 years
- History of Orthognathic surgery
- Not Caucasian
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 |
|---|---|---|
| 3D stereophotogrammetric imaging | Procedure or surgery | – |
| 3D CT-imaging with cone-beam CT | Procedure or surgery | – |
| Case report form | Procedure or surgery | – |
Primary outcome
All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.
3 secondary outcomes
All postoperative changes in functionality at 1 year
patients' satisfaction of facial proportions at 1 year
surgeons' satisfaction of the 3D planning platform at 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2007.
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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.
Stefaan J Bergé, Prof, MD, DMD, PhD, study director
Radboud University Medical Center
Filip AC Schutyser, MsC principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D stereophotogrammetric imaging, 3D CT-imaging with cone-beam CT and Case report form in people with Craniofacial Abnormalities and Maxillofacial Abnormalities, run by Radboud University Medical Center at 3 sites in Netherlands.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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 Joanneke Plooij, MD (+31-24-3619464, j.plooij@mka.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 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 27 Jul 2007.