Macrogenia Clinical Trial
Official title:
Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty
| NCT number | NCT03647865 |
| Other study ID # | 2018 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2018 |
| Est. completion date | October 2019 |
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.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | October 2019 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Cairo University | Cairo | Manial |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |