Cleft Lip, Cleft Palate, Craniofacial Abnormalities, Maxillofacial Abnormalities
Conditions
Keywords
3D computer assisted imaging, maxillofacial surgery, cephalometry, normative value
Brief summary
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.
Interventions
PROCEDURE3D stereophotogrammetric imaging
PROCEDURE3D CT-imaging with cone-beam CT
PROCEDURECase report form
Sponsors
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dysgnathic deformity * Caucasian * \> 15 years * No history of orthognathic surgery * Informed Consent
Exclusion criteria
* \< 15 years * History of Orthognathic surgery * Not Caucasian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| All postoperative changes in functionality at 1 year | — |
| patients' satisfaction of facial proportions at 1 year | — |
| surgeons' satisfaction of the 3D planning platform at 1 month | — |
Countries
Netherlands
Contacts
Primary ContactJoanneke Plooij, MD
Backup ContactThomas Maal, MsC
Outcome results
None listed