Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03986723
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03986723


Locations
Layout table for location information
Belgium
AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium
Sponsors and Collaborators
AZ Sint-Jan AV

Layout table for additonal information
Responsible Party: Gwen Swennen, maxillofacial surgeon, principal investigator, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03986723     History of Changes
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

Layout table for additional information
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
reliability
time efficiency