Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Accuracy Of the Custom Made Miniplate
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Patients need genioplasty
Intervention: Osseous Genioplasty (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Patient Satisfaction (Esthetics)(one year)
Investigators
Mina Nazih Zaki Sedrak
Principal Investigator
Cairo University