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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03647865
Enrollment
10
Registered
2018-08-27
Start date
2018-09-30
Completion date
2019-10-31
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macrogenia, Microgenia, Miniplate

Keywords

Computer Guided,, Osseous Genioplasty, Custom Made Titanium Plates, Orthognathic Surgery, Genioplasty, patient Specific device

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.

Interventions

PROCEDUREOsseous Genioplasty

Surgical Procedure that cuts the chin and reposition it in the correct place

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy Of the Custom Made Miniplateone yearHausdorff 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

MeasureTime frameDescription
Patient Satisfaction (Esthetics)one yearQuestionnaire 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).

Countries

Egypt

Contacts

Primary ContactMina Na Sedrak
mina.nazih87@gmail.com00201223870114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026