About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
Patients with no signs or symptoms of active TMDs.
Highly motivated patients.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
minimally invasive maxillary fixation
Procedure/Surgery3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress
Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.
Procedure/Surgery3d printed custom plates fixing maxilla on nasal and zygomatic buttresses via conventional vestibular approach.
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
linear measurement of discrepancy between both scans after superimposition
Secondary outcomes
Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans
linear measurement of discrepancy between both scans after superimposition
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: