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

NCT02660021 | Unknown

• 1 other identifier: B049201627035
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.

Conditions

Jaw Abnormalities

Keywords

three-dimensional virtual treatment planning; orthognathic surgery

Outcome Measures

Primary Outcomes (1)

• Accuracy of hard tissue, soft tissue and teeth transfer after 3D planning, as measured with CBCT

  within 12 months postoperative

Secondary Outcomes (5)

• Prevalence of patients with an indication for orthognathic surgery

  6 years

• Accuracy of bone transfer, as measured through superimposition of 3D planning CBCT and postoperative CBCT

  4 weeks postoperative

• Long-term stability, through clinical evaluation and superimposition of 3D planning CBCT and postoperative CBCT

  6 months postoperative

• number of patients with condylar resorption

  until 12 months postoperative

• number of patients with temporomandibular joint complications

  until 12 months postoperative

Other Outcomes (1)

• sample size calculation for future large prospective trials, based on pilot data

  6 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

General Hospital Saint-John Bruges

Bruges, Belgium

RECRUITING

MeSH Terms

Conditions

Jaw Abnormalities

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS

  Maxillofacial Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Araceli Diez-Fraile, VMD PhD

CONTACT

araceli.diez-fraile@azsintjan.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: maxillofacial surgeon, MD, LDS, DMD, PhD, FEBOMFS

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 21, 2016
• Study Start: July 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)