Orthognathic SurgeryNCT03986723
3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
An observational study of Orthognathic Surgery, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthognathic Surgery
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2017to 31 Mar 2018
- 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: consecutive orthognathic cases planned with 3D virtual planning software
Who may be able to join
- planned for orthognathic surgery
- planning by a single resident
- planning based on 3D virtual workflow
Who cannot join
- not eligible according to abovementioned criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Implementation of 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow.
Twenty real-life cases were planned according to both workflows and timed by a single resident.
- Conditions
- Orthognathic Surgery
- Keywords
- traditional plaster model, 3D printed model, digital workflow, reliability, time efficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer
duration of the complete workflow, measured in seconds with a digital chronometer
Measured: preoperative
Secondary outcomes (1)
reliability of the workflow through registration of problems, difficulties that occur
evaluation of the reliability of the workflow through registration of problems, difficulties that occur
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start29 Nov 2017
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies 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
- 20 participants (actual)
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 PhD, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986723
- Sponsor's protocol ID
- 2241
- Status last verified
- Jan 2021
- First submitted
- 14 Feb 2019
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implementation of 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT03986723
- Acronym / sponsor ID
- 2241
- Conditions
- Orthognathic Surgery
- Keywords
- traditional plaster model, 3D printed model, digital workflow, reliability, time efficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 14 Jun 2019 (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.
Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow.
Twenty real-life cases were planned according to both workflows and timed by a single resident.
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
- consecutive orthognathic cases planned with 3D virtual planning software
Key inclusion criteria (3 listed)
- planned for orthognathic surgery
- planning by a single resident
- planning based on 3D virtual workflow
Key exclusion criteria (1 listed)
- not eligible according to abovementioned criteria
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
time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer
Time frame: preoperative
duration of the complete workflow, measured in seconds with a digital chronometer
1 secondary outcome
reliability of the workflow through registration of problems, difficulties that occur
Time frame: preoperative
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 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.
Gwen Swennen, MD PhD principal investigator
AZ Sint-Lucas Brugge
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 Orthognathic Surgery, 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 3 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: finished, 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?
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?
time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer (time frame: preoperative). 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.