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3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

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: NCT03986723
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:

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.

Condition or disease
Orthognathic Surgery

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Implementation of 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 31, 2018

Primary Outcome Measures :
  1. time efficiency [ Time Frame: preoperative ]
    duration of the complete workflow, measured in seconds with a digital chronometer

Secondary Outcome Measures :
  1. reliability [ Time Frame: preoperative ]
    evaluation of the reliability of the workflow through registration of problems, difficulties that occur

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 cases planned with 3D virtual planning software

Inclusion Criteria:

  • planned for orthognathic surgery
  • planning by a single resident
  • planning based on 3D virtual workflow

Exclusion Criteria:

  • not eligible according to abovementioned criteria

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): NCT03986723

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AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium
Sponsors and Collaborators
AZ Sint-Jan AV
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Responsible Party: Gwen Swennen, maxillofacial surgeon, principal investigator, AZ Sint-Jan AV Identifier: NCT03986723    
Other Study ID Numbers: 2241
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:
traditional plaster model
3D printed model
digital workflow
time efficiency