Orthognathic Surgery
Conditions
Keywords
orthognathic, minimally invasive, nasal buttress, custom plate
Brief summary
The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is: • Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable. Participants will: * Undergo surgey * Follow up visits weekly for a month then on a monthly basis for 5 more months.
Interventions
PROCEDUREminimally invasive maxillary fixation
3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress
PROCEDUREMaxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.
3d printed custom plates fixing maxilla on nasal and zygomatic buttresses via conventional vestibular approach.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries. * Patients with no signs or symptoms of active TMDs. * Highly motivated patients.
Exclusion criteria
* Patients who refused to be included in the research. * Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia. * Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans. | from preoperative plan to immediate postoperative (1 week) | linear measurement of discrepancy between both scans after superimposition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans | from enrollment to 6 month postoperative | linear measurement of discrepancy between both scans after superimposition |
Contacts
Primary ContactMahmoud H Khorshed, MSc
Outcome results
None listed