Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty
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|ClinicalTrials.gov Identifier: NCT03647865|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Macrogenia Microgenia Miniplate||Procedure: Osseous Genioplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||October 2019|
|Experimental: Patients need genioplasty||
Procedure: Osseous Genioplasty
Surgical Procedure that cuts the chin and reposition it in the correct place
- Accuracy Of the Custom Made Miniplate [ Time Frame: one year ]
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.
- Patient Satisfaction (Esthetics) [ Time Frame: one year ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647865
|Contact: Mina Na Sedrakfirstname.lastname@example.org|
|Cairo, Manial, Egypt, 002|
|Study Director:||Nader Na Elbokle, Phd Holder||Cairo University|