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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

NCT03647865 — Not applicable, Unknown, 10 participants, Cairo University

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RegistryNCT03647865
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment10 (Estimated)
SponsorCairo University (Other)
ConditionsMacrogenia, Microgenia, Miniplate
InterventionsOsseous Genioplasty (Procedure)
Datesstart 2018-09-01 (estimated), primary completion 2019-09-01 (estimated), completion 2019-10-01 (estimated), first posted 2018-08-27, last updated 2018-09-18
Locations1 site in Egypt

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Patients need genioplastyExperimentalProcedure: Osseous Genioplasty
  • Osseous Genioplasty (Procedure): Surgical Procedure that cuts the chin and reposition it in the correct place

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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).

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Cairo UniversityCairo, ManialEgyptRecruiting

+Investigators

My Notes