NCT03986723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

February 14, 2019

Last Update Submit

January 15, 2021

Conditions

Orthognathic Surgery

Keywords

traditional plaster model3D printed modeldigital workflowreliabilitytime efficiency

Outcome Measures

Primary Outcomes (1)

  • time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer

    duration of the complete workflow, measured in seconds with a digital chronometer

    preoperative

Secondary Outcomes (1)

  • reliability of the workflow through registration of problems, difficulties that occur

    preoperative

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive orthognathic cases planned with 3D virtual planning software

You may qualify if:

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

You may not qualify if:

  • not eligible according to abovementioned criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

Study Officials

  • Gwen Swennen, MD PhD

    AZ Sint-Lucas Brugge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
maxillofacial surgeon, principal investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

June 14, 2019

Study Start

November 29, 2017

Primary Completion

December 31, 2017

Study Completion

March 31, 2018

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)