Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery (3D-VIRTOG)

January 15, 2021 updated by: Gwen Swennen, AZ Sint-Jan AV

Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and face that are related to structure or growth malfunctioning, orthodontic problems, or co-morbidities associated with skeletal disfigurement.

Imaging is crucial in the assessment and treatment planning of orthognathic surgery patients. Until recently, two-dimensional (2D) imaging, through cephalometry, was standard practice. However, it showed several limitations. The introduction of the cone-beam computed tomography (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift. Though widespread implementation in routine practice is not yet present. Our department is one of the pioneers in the world of 3D virtual treatment planning for orthognathic surgery. The "triple CBCT scan procedure" has been developed in-house and implemented already in 2009.

The investigators aim to develop a prospective database registering 3D treatment planning data of all consecutive patients eligible for orthognathic surgery, performed by Prof. Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and orthognathic surgery data are being collected during consecutive visits within the framework of routine practice.

Development of a database registering 3D virtual treatment planning data of orthognathic surgery, will provide more information about potential patient, virtual planning and surgical factors influencing postoperative accuracy of jaw correction, long-term stability of the jawbone, long-term condylar resorption, or soft tissue response. In general, it could provide answers on research questions that have been examined in prior studies on 2D-imaging, but can now be re-examined in case of 3D-imaging. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Bruges, Belgium
        • Recruiting
        • General Hospital Saint-John Bruges
        • Contact:
        • Principal Investigator:
          • Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consenting patients, eligible for orthognathic surgery, performed at the General Hospital Saint-John Bruges, from July 1st 2010 onwards.

Description

Inclusion Criteria:

  • Patients of all ages
  • Both female and male patients
  • Patients should present themselves at the Department of Oral and Maxillofacial Surgery of the General Hospital Saint-John Bruges for orthognathic surgical treatment
  • Patients receive standardized cone-beam computed tomography (CBCT) image acquisition (i-CAT, Imaging sciences international, inc, Hatfield, USA) according to the "triple" CBCT scan protocol
  • Patients' orthognathic surgery should be prepared by a standardized setup of an augmented 3D virtual patient model in centric relation, with detailed occlusal and intercuspidation data using the "triple" voxel-based rigid registration protocol (Maxilim v2.2.2., Nobel Biocare c/o Medicim nv, Mechelen, Belgium)
  • Patients' surgery should be prepared preoperatively through 3D virtual planning steps performed with the same software, by the same surgeon (GS)
  • Patients should be operated by the same surgeon (GS)

Exclusion Criteria:

  • All patients that do not fit in the abovementioned description
  • Patients with posttraumatic deformity
  • Patients with congenital deformity
  • Patients with preprosthetic indication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of hard tissue, soft tissue and teeth transfer after 3D planning, as measured with CBCT
Time Frame: within 12 months postoperative
within 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of patients with an indication for orthognathic surgery
Time Frame: 6 years
6 years
Accuracy of bone transfer, as measured through superimposition of 3D planning CBCT and postoperative CBCT
Time Frame: 4 weeks postoperative
4 weeks postoperative
Long-term stability, through clinical evaluation and superimposition of 3D planning CBCT and postoperative CBCT
Time Frame: 6 months postoperative
6 months postoperative
number of patients with condylar resorption
Time Frame: until 12 months postoperative
until 12 months postoperative
number of patients with temporomandibular joint complications
Time Frame: until 12 months postoperative
until 12 months postoperative

Other Outcome Measures

Outcome Measure
Time Frame
sample size calculation for future large prospective trials, based on pilot data
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS, Maxillofacial Surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B049201627035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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