Craniofacial Surgery, Virtual Surgical Planning
Conditions
Brief summary
The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan
Detailed description
The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome. The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.
Interventions
PROCEDUREvirtual surgical planning and patient specific implants in craniomaxillofacial reconstruction
Image acquisition by computed tomography (CT slice thickness 1 mm or less) + laser scanning of patient models. Virtual surgical planning and design of patient specific implants. Patient specific implants manufacturing (milling technique) and 3D printing of surgical guides and fit models.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 47 Years
Healthy volunteers
No
Inclusion criteria
* Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to: * Trauma. * Tumor resection (either by immediate or delayed reconstruction). * Complex congenital and dentofacial deformities.
Exclusion criteria
* Patients with special needs. * Medically compromised patients who are not fit for surgery. * Irradiated patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance deviation | Immediate post operative | the accuracy of reconstruction, defined as linear deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans |
| Angular deviation | Immediate post operative | the accuracy of reconstruction, defined as angulation deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in post operative aesthetic results of surgery | 1 week, 4 weeks, 8 weeks, and 6 months | aesthetic scale from zero to 5 * 5 points - changes are not visually noticeable. * 4 points - changes in appearance are barely noticeable and do not affect the patient's quality of life. * 3 points - aesthetic deficit that does not require surgical correction. * 2 points - aesthetic defects require minor surgical corrections in the postoperative period. * 1 point - significant aesthetic defects require serious (often multi-stage surgical correction). * 0 points - the presence of severe aesthetic defects that cannot be eliminated. |
| change in Quality of Life (QOL) | 1 week, 4 weeks, 8 weeks, and 6 months | Scores as follow 0 = much better. 1. = better. 2. = the same. 3. = worse. 4. = much worse |
Countries
Egypt
Outcome results
None listed