Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty

Study Overview
=================
Brief Summary
-----------------
In patients with chin deformeties, will using a custom made titanium plate in the positioning of the genial segments give an accurate results in comparison to the preoperative planned osteotomy and move of the Genioplasty.

Official Title
-----------------
Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty

Conditions
-----------------
Microgenia, Macrogenia, Miniplate

Intervention / Treatment
-----------------
* Procedure: Osseous Genioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with genial deformeties that require surgical correction. Patients with chin asymmetry. Patients older than 18 years old. Exclusion Criteria: Patients with uncontrolled systemic disease (Diabetes Mellitus). Previous Radiotherapy to the area of interest. Patients on bisphosphonates therapy. Patients underwent previous or concomitant mandibular orthognathic surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients need genioplasty<br> | Procedure: Osseous Genioplasty<br>* Surgical Procedure that cuts the chin and reposition it in the correct place<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy Of the Custom Made Miniplate | Hausdorff function analysis (Topographic Color Mapping) by superimposition of both preoperative and postoperative computed tomography 3D scans and obtaining numerical values. Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) vs.21. Numerical data will be summarized using means and standard deviations or median and range as appropriate. Correlation analysis between Accuracy of computer assisted custom made plate and preoperative 3D virtual planning will be done using Pearson or Sperman rho as appropriate. Paired t test will be done and equivelance limit will be tested. All p- values are two sided. P- Values <0.05 will be considered significant. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction (Esthetics) | Questionnaire with numerical scale ranging from minimal score ( number 1) to maximum score (number 10) in ascending manner where the minimal score indicated unpleasant or unsatisfactory result ( doesn't meet the patient expectation) and maximum score indicated satisfactory and pleasant result (fully meets patient satisfaction). | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computer Guided,, Osseous Genioplasty, Custom Made Titanium Plates, Orthognathic Surgery, Genioplasty, patient Specific device