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Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study (IPSCD-TIM-GS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03986710
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Information provided by (Responsible Party):
Gwen Swennen, AZ Sint-Jan AV

Brief 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. 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.

Condition or disease
Orthognathic Surgery

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : February 28, 2017

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. duration of 8 major steps in 3D virtual treatment planning [ Time Frame: preoperative ]
    duration of 8 major steps in 3D virtual treatment planning, measured in seconds with a digital online chronometer

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive orthognathic patients operated and planned by a single surgeon (GS)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • All patients that do not fit the abovementioned description
  • Patients with posttraumatic deformity
  • Patients with congenital deformity
  • Patients with pre-prosthetic indication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03986710

Sponsors and Collaborators
AZ Sint-Jan AV
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Principal Investigator: Gwen Swennen AZ Sint-Jan Brugge-Oostende AV
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Responsible Party: Gwen Swennen, maxillofacial surgeon, principal investigator, AZ Sint-Jan AV Identifier: NCT03986710    
Other Study ID Numbers: 2004
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gwen Swennen, AZ Sint-Jan AV:
3D virtual planning software