Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis

Study Overview
=================
Brief Summary
-----------------
Virtual Surgical planning (VSP) has significantly improved many aspects of oral and maxillofacial surgery. A very important aspect is surgical accuracy and precise transfer of the surgical plan to the operating theatre and reduction of operative time. Conventional treatment planning for orthognathic surgery, although proven to be reliable, has many drawbacks. Computer guided splintless maxillary orthognathic surgery has been recently performed with predictable outcomes. More than one design of PS osteosynthesis has been used in recent trials. Nevertheless, which design is more superior to the other is a topic yet to be addressed. Either a one-piece fixation device spanning the length of the Le Fort 1 osteotomy or the fixation can be provided by more than one device placed at the load bearing buttresses. The superiority of 4 fixating patients specific plates compared to the other will be determined after evaluating many outcomes including accuracy, intra operative time, post-operative complications. The goal is to take a step towards determining which design is the best for performing splintless maxillary orthognathic surgery in terms of accuracy and least complications for the correction of prevalent dentofacial deformities. Beside the evaluation of accuracy, the two different designs will be compared in terms of operative time and post-operative complications.

Official Title
-----------------
Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis. A Randomized Clinical Trial

Conditions
-----------------
Le Fort; I

Intervention / Treatment
-----------------
* Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry. Patient seeking definitive maxillary or bimaxillary surgical correction and refusing orthodontic camouflage. Patient due to receive a non- segmental Le Fort I osteotomy as part of their orthognathic surgery. Patient age at least 18 years Highly motivated patients. Good oral hygiene. Patients willing for follow-up, with an informed consent Exclusion Criteria: Medically compromised patients redeeming unfit for general anesthesia Pregnancy patient had a known allergy to titanium Patients with any diseases that may compromise bone or soft tissue healing. Patients with local pathosis that may interfere with the bone healing. Patient with previous maxillary surgery having hardware that may compromise accuracy of the virtual planning

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)<br> | Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)<br>* Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)<br>|
| No Intervention: Maxillary orthognathic surgery using 2 patient specific osteosynthesis (2-Plates)<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Primary outcome will be the positional accuracy of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 1-week postoperative CT with the planned one and the difference is calculated in mm. | 1 week |