Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries: A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Primary Endpoint
- Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
Time Frame: from preoperative plan to immediate postoperative (1 week)
linear measurement of discrepancy between both scans after superimposition
Secondary Outcomes
- Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans(from enrollment to 6 month postoperative)
Investigators
Mahmoud Hamid Khorshed
oral & maxillofacial surgeon
Cairo University