Clinical Trial: Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title:

Brief 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 functio

Detailed Summary:
Sponsor: AZ Sint-Jan AV

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: AZ Sint-Jan AV

Dates:
Date Received: January 11, 2016
Date Started: July 2010
Date Completion: December 2017
Last Updated: January 18, 2016
Last Verified: January 2016