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Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817930
Recruitment Status : Completed
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Shawky, Cairo University

Study Description
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Brief Summary:
Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year

Condition or disease Intervention/treatment Phase
Chin Microgenia Device: Polyetheretherketone patient specific implant Device: Computer guided advancement genioplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patient specific chin implant
A patient specific chin peek implant was used for chin augmentation
 Device: Polyetheretherketone patient specific implant
a customized peek patient specific implant is place to augment the chin
Experimental: computer guided advancement genioplasty
Computer guided advancement genioplasty using patient specific cutting and positioning guides
 Device: Computer guided advancement genioplasty
advancement genioplasty using patient specific cutting and positioning surgical stents


Outcome Measures
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Primary Outcome Measures :
  1. soft tissue effect [ Time Frame: after one year ]
    The impact of the interventions on the soft tissue gain after one year


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only
  • No prior surgery involving the chin

Exclusion Criteria:

  • Patients whose clinical features revealed possible correction of their facial deformity using mandibular surgeries.
  • Patients with systemic diseases that carried high risk for general anesthesia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817930


Locations
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Egypt
Faculty of Dentistry
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohamed Shawky Assistant lecturer. OMFS. Cairo University
More Information
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Responsible Party: Mohamed Shawky, Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up, Cairo University
ClinicalTrials.gov Identifier: NCT04817930    
Other Study ID Numbers: OMFS 3-3-6
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: intervention and effect and demographic data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohamed Shawky, Cairo University:
Chin microgenia
Orthognathic