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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
Sponsor:
Information provided by (Responsible Party):
Mina Nazih Zaki Sedrak, Cairo University

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.

Condition or disease Intervention/treatment Phase
Macrogenia Microgenia Miniplate Procedure: Osseous Genioplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Patients need genioplasty Procedure: Osseous Genioplasty
Surgical Procedure that cuts the chin and reposition it in the correct place




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mina Na Sedrak 00201223870114 mina.nazih87@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Manial, Egypt, 002
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Nader Na Elbokle, Phd Holder Cairo University

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Responsible Party: Mina Nazih Zaki Sedrak, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03647865     History of Changes
Other Study ID Numbers: 2018
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mina Nazih Zaki Sedrak, Cairo University:
Computer Guided,
Osseous Genioplasty
Custom Made Titanium Plates
Orthognathic Surgery
Genioplasty
patient Specific device