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

Not Applicable

• Conditions: Microgenia; Macrogenia; Miniplate
• Interventions: Procedure: Osseous Genioplasty

• Registration Number: NCT03647865
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-19
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Status Verified: 2018-09
• Study Start: 2018-09
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with genial deformeties that require surgical correction.
• Patients with chin asymmetry.
• Patients older than 18 years old.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients need genioplasty	Osseous Genioplasty	-

Primary Outcome Measures

Name	Time	Method
Accuracy Of the Custom Made Miniplate	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

Name	Time	Method
Patient Satisfaction (Esthetics)	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).

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Manial, Egypt