Registry for 3D Virtual Treatment Planning in Jaw Surgery
Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery
This study is trying to see if using 3D imaging technology can help improve the planning and results of jaw surgery for patients with jaw abnormalities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT02660021 on ClinicalTrials.gov |
What this trial studies
This study aims to create a prospective database that registers 3D treatment planning data for patients undergoing orthognathic surgery at the General Hospital Saint-John Bruges. It focuses on utilizing advanced cone-beam computed tomography (CBCT) to improve the accuracy and effectiveness of surgical planning. By implementing a standardized approach to 3D virtual patient modeling, the study seeks to enhance the surgical outcomes for patients with jaw abnormalities. The research is pioneering in its use of 3D imaging technology in this field.
Who should consider this trial
Good fit: Ideal candidates include patients of all ages presenting for orthognathic surgical treatment at the General Hospital Saint-John Bruges.
Not a fit: Patients who do not meet the eligibility criteria or those requiring different surgical approaches may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and patient satisfaction for those undergoing corrective jaw surgery.
How similar studies have performed: While the use of 3D imaging in orthognathic surgery is gaining traction, this specific approach is among the first to systematically register and analyze such data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bruges
- General Hospital Saint-John Bruges — Bruges, Belgium (Recruiting)
Study contacts
- Principal investigator: Gwen Swennen, MD, LDS, DMD, PhD, FEBOMFS — Maxillofacial Surgeon
- Study coordinator: Araceli Diez-Fraile, VMD PhD
- Email: araceli.diez-fraile@azsintjan.be
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.