Orthognathic Surgery3D IPSCD-TIMNCT03843138
Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study
An observational study of Orthognathic Surgery, run by AZ Sint-Jan AV.
Trial summary
Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthognathic Surgery
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 31 Mar 2017
- 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
- Child, Adult, Older adult
Study population: All consecutive patients who present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery between May and August 2016
Who may be able to join
- Patients of all ages
- Patients of both genders
- Patients should present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery
- Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
- Preoperative 3D virtual planning should be performed by the same investigator per center with the IPSCD software
Who cannot join
- All patients that do not fit the abovementioned description
- Patients with posttraumatic deformity
- Patients with congenital deformity
- Patients with pre-prosthetic indication
About this study
Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD).
Objectives The investigators aim to test pre-release versions of the IPSCD software under real-world working conditions in strictly selected university, general and private hospital settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.
Read more
Study design closed beta-phase; international, multi-centric, prospective study Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all the virtual planning steps with the novel software. Timing of the eight major steps will be measured with a digital chronometer.
One hundred and eight patient cases will be planned with the IPSCD software in the participating centers over a period of three months, in the order of respectively one, three and five cases per month per participating center.
Investigators will register anonymized patient demographics (age, gender, clinical diagnosis, type of surgery), and provide feedback regarding the required time to complete the different surgical planning steps, regarding the number of failed alignments, and the occurrence of software bugs. Intergroup comparison of virtual planning time between the different centers will be analyzed. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon and/or orthodontist, or in comparison to the initial beta-testing phase results by GS.
- Conditions
- Orthognathic Surgery
- Keywords
- 3D virtual planning software, Individual Patient Solutions Case Designer (IPSCD), timing, international, multicenter
What is being measured
The primary outcome is the main question the study is designed to answer.
required time to complete total 3D virtual planning
required time to complete total 3D virtual planning, measured in seconds with a digital chronometer
Measured: preoperative
Secondary outcomes (1)
required time to complete the 8 major virtual planning steps
required time to complete the 8 major virtual planning steps, measured in seconds with a digital chronometer
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startMay 2016
- Primary completion30 Sep 2016
- Study completion31 Mar 2017
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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Göttingen, Esbjerg Hospital - University Hospital of Southern Denmark, University Hospital Heidelberg, AZ Monica Campus Antwerpen, Academisch Ziekenhuis Maastricht, Radboud University Medical Center
- Responsible party
- Principal investigator, Gwen Swennen, AZ Sint-Jan AV
- Investigators
- Gwen Swennen, Principal investigator, department of maxillofacial surgery, AZ Sint-Jan Brugge-Oostende AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843138
- Sponsor's protocol ID
- 2004-MC
- Acronym
- 3D IPSCD-TIM
- Status last verified
- Jun 2019
- First submitted
- 14 Feb 2019
- Last updated
- 17 Jun 2019
- 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 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study
- ClinicalTrials.gov ID
- NCT03843138
- Acronym / sponsor ID
- 3D IPSCD-TIM / 2004-MC
- Conditions
- Orthognathic Surgery
- Keywords
- 3D virtual planning software, Individual Patient Solutions Case Designer (IPSCD), timing, international, multicenter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Göttingen, Esbjerg Hospital - University Hospital of Southern Denmark, University Hospital Heidelberg, AZ Monica Campus Antwerpen, Academisch Ziekenhuis Maastricht, Radboud University Medical Center
- Study start
- May 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Feb 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.
Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD).
Objectives The investigators aim to test pre-release versions of the IPSCD software under real-world working conditions in strictly selected university, general and private hospital settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.
Study design closed beta-phase; international, multi-centric, prospective study Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all the virtual planning steps with the novel software. Timing of the eight major steps will be measured with a digital chronometer.
One hundred and eight patient cases will be planned with the IPSCD software in the participating centers over a period of three months, in the order of respectively one, three and five cases per month per participating center.
Investigators will register anonymized patient demographics (age, gender, clinical diagnosis, type of surgery), and provide feedback regarding the required time to complete the different surgical planning steps, regarding the number of failed alignments, and the occurrence of software bugs. Intergroup comparison of virtual planning time between the different centers will be analyzed. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon and/or orthodontist, or in comparison to the initial beta-testing phase results by GS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients who present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery between May and August 2016
Key inclusion criteria (5 listed)
- Patients of all ages
- Patients of both genders
- Patients should present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery
- Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
- Preoperative 3D virtual planning should be performed by the same investigator per center with the IPSCD software
Key exclusion criteria (4 listed)
- All patients that do not fit the abovementioned description
- Patients with posttraumatic deformity
- Patients with congenital deformity
- Patients with pre-prosthetic 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
required time to complete total 3D virtual planning
Time frame: preoperative
required time to complete total 3D virtual planning, measured in seconds with a digital chronometer
1 secondary outcome
required time to complete the 8 major virtual planning steps
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 17 Jun 2019.
- 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 principal investigator
department of maxillofacial surgery, AZ Sint-Jan Brugge-Oostende AV
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery, run by AZ Sint-Jan AV.
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 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: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
required time to complete total 3D virtual planning (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 17 Jun 2019.