Dentofacial anomalies CID K07.9
Conditions
Interventions
The clinical project has two groups, control (G1) and experimental (G2), where the same interventions will be performed. The difference between the control and experimental groups concerns only the fi
Procedure/surgery
E06.892
Sponsors
Faculdade de Ciências da Saúde, Universidade de Brasília
Hospital Universitário de Brasília
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age equal or superior to 18 years; healthy; no history of temporomandibular dysfunction (TMD); of any gender; that are not in continuous use of medications that may interfere with bone repair / metabolism; with indication of surgical correction of combined dentomaxillofacial deformities (maxilla and mandible, maxilla, mandible and mento); who present orthodontic appliances already in the final stage of preoperative preparation for surgery and who have not received radiotherapy in the head and neck region.
Exclusion criteria
Exclusion criteria: complications with the non-adaptation of the customized fixation system; postoperative infection; need surgical intervention and removal of the system (any of the two systems employed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mainly, it is expected that the difference between the actual positioning of the maxilla and the mandible postoperatively and the virtual of the plate used in the G2 group of customized plates is not inferior to the plate used in the G1 group of conventional plates, that is: the custom board offers security and efficiency of use as conventional boards. To do so, a postoperative tomography will be performed, and the actual position of the maxilla and mandible obtained by the 3D reconstruction of the tomography will be compared with the maxillary position of the virtual surgical planning (PCV). This comparison will have the objective of evaluating the actual final positioning with the planned one between the two rigid internal fixation systems: conventional and customized. The comparison between the PCV and the maxillary maxillary position will be performed by the free GOM Inspect® software. Markings at specific points in the maxilla will be made to form a pentagram (plane) to analyze the final positions of the maxillomandibular joint in the sagittal, transverse and vertical planes, generating linear measurements that will be compared intra and intergroups.;Secondly, less surgical time is expected, which will be timed as follows: the total time of surgery, from the time of the beginning of the first anesthetic infiltration to the completion of the last suture, in minutes. Time of manipulation of the plates, both in group G1 and in group G2, will be timed in the following order: for group G1, after installation of the surgical guide and verification of correct bone positioning, the time marking will begin in the manipulation of the plates fixing, to prepare them (fold them), check the adaptation and fixation, stopping the stopwatch at the end of the installation of the last screw of the last plate installed (for both maxilla and jaw); for group G2, after installation of the surgical guide and verification of correct bone positioning, the time marking will begin, from t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactAndré;Hospital Vieira Cortez;de Brasília
Faculdade de Ciências da Saúde, Universidade de Brasília;Hospital Universitário de Brasília
Outcome results
None listed