Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedSeptember 18, 2018
September 1, 2018
1 year
May 19, 2018
September 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy Of the Custom Made Miniplate
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.
one year
Secondary Outcomes (1)
Patient Satisfaction (Esthetics)
one year
Study Arms (1)
Patients need genioplasty
EXPERIMENTALInterventions
Surgical Procedure that cuts the chin and reposition it in the correct place
Eligibility Criteria
You may qualify if:
- Patients with genial deformeties that require surgical correction.
- Patients with chin asymmetry.
- Patients older than 18 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Manial, 002, Egypt
Study Officials
- STUDY DIRECTOR
Nader Na Elbokle, Phd Holder
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 19, 2018
First Posted
August 27, 2018
Study Start
September 1, 2018
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
September 18, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share