Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery

Last updated: January 15, 2021
Sponsor: AZ Sint-Jan AV
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02660021
B049201627035
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of all ages
  • Both female and male patients
  • Patients should present themselves at the Department of Oral and Maxillofacial Surgeryof 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 anaugmented 3D virtual patient model in centric relation, with detailed occlusal andintercuspidation 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 stepsperformed with the same software, by the same surgeon (GS)
  • Patients should be operated by the same surgeon (GS)

Exclusion

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 Design

Total Participants: 1000
Study Start date:
July 01, 2010
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • General Hospital Saint-John Bruges

    Bruges,
    Belgium

    Active - Recruiting

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