Orthognathic SurgeryIPSCD-TIM-GSNCT03986710
Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 28 Feb 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive orthognathic patients operated and planned by a single surgeon (GS)
Who may be able to join
- Patients of all ages
- Patients of both genders
- Patients should present themselves at the division of Maxillofacial 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 surgeon
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 phase of their novel 3D virtual planning software, "IPS (Individual Patient Solutions) CaseDesigner (IPSCD)".
Objectives The authors aim to test pre-release versions of the IPSCD software under real-world working conditions by a single surgeon.In specific, the authors aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.
Study design closed beta-phase 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 will run all the virtual planning steps with both conventional software (Maxilim) and the novel software. Timing of the eight major steps will be measured with a digital chronometer.
- Conditions
- Orthognathic Surgery
- Keywords
- 3D virtual planning software, timing
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of total 3D virtual treatment planning time
duration of total 3D virtual treatment planning time, measured in seconds with a digital online chronometer
Measured: preoperative
Secondary outcomes (1)
duration of 8 major steps in 3D virtual treatment planning
duration of 8 major steps in 3D virtual treatment planning, measured in seconds with a digital online 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 posted14 Jun 2019
- Study startApr 2016
- Primary completion31 Jul 2016
- Study completion28 Feb 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
- 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, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986710
- Sponsor's protocol ID
- 2004
- Acronym
- IPSCD-TIM-GS
- Status last verified
- Jun 2019
- First submitted
- 14 Feb 2019
- Last updated
- 14 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 14 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: Single Surgeon Study
- ClinicalTrials.gov ID
- NCT03986710
- Acronym / sponsor ID
- IPSCD-TIM-GS / 2004
- Conditions
- Orthognathic Surgery
- Keywords
- 3D virtual planning software, timing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 28 Feb 2017 (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.
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 phase of their novel 3D virtual planning software, "IPS (Individual Patient Solutions) CaseDesigner (IPSCD)".
Objectives The authors aim to test pre-release versions of the IPSCD software under real-world working conditions by a single surgeon.In specific, the authors aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.
Study design closed beta-phase 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 will run all the virtual planning steps with both conventional software (Maxilim) and the novel software. Timing of the eight major steps will be measured with a digital chronometer.
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 patients operated and planned by a single surgeon (GS)
Key inclusion criteria (5 listed)
- Patients of all ages
- Patients of both genders
- Patients should present themselves at the division of Maxillofacial 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 surgeon
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
duration of total 3D virtual treatment planning time
Time frame: preoperative
duration of total 3D virtual treatment planning time, measured in seconds with a digital online chronometer
1 secondary outcome
duration of 8 major steps in 3D virtual treatment planning
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 14 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Orthognathic Surgery
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Recruiting
Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates
Orthognathic Surgery
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
RecruitingObservational study
Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device
TMD/Orofacial Pain, Malocclusions
Not yet recruiting
Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery
Infraorbital Nerve Injury, Inferior Alveolar Nerve Injury
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
AZ Sint-Lucas Brugge
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 14 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?
duration of total 3D virtual treatment planning time (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 14 Jun 2019.