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The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency

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: NCT03577210
Recruitment Status : Unknown
Verified July 2018 by Salma Hassan Abd el-Aty, Cairo University.
Recruitment status was:  Recruiting
First Posted : July 5, 2018
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Salma Hassan Abd el-Aty, Cairo University

Study Description
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Brief Summary:
computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.

Condition or disease Intervention/treatment Phase
Chin Microgenia Procedure: augmentation genioplasty Not Applicable

Detailed Description:
augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019
Arms and Interventions
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Arm Intervention/treatment
computer-guided augmentation genioplasty
patient-specific PEEK implant
 Procedure: augmentation genioplasty
augmentation genioplasty with patient-specific PEEK implant


Outcome Measures
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Primary Outcome Measures :
  1. degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm [ Time Frame: two weeks postoperative ]
    degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm


Secondary Outcome Measures :
  1. patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire [ Time Frame: 6 months postoperative ]
    degree of patient satisfaction using Face-Q questionnaire with score from 0-100 where 0 shows least degree of satisfaction and 100 shows best degree of satisfaction.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female patients.
  • Patients with retruded chin or with chin asymmetry.
  • Patients with good oral hygiene.

Exclusion Criteria:

  • Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
  • Patients with medical condition that may compromise the healing process.
  • Patients with medical condition that is contraindicated for general anaesthesia.
  • Presence of pathological lesion related to chin area.
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): NCT03577210


Contacts
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Contact: salma h Abd el-Aty, MSc 0201113999772 salmadent@gmail.com
Contact: salma h Abd el-Aty, MSc 0201005113060 s7_86@hotmail.com

Locations
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Egypt
Salma Hassan Recruiting
Cairo, Egypt, 21111
Contact: salma hassan, MSc    0201113999772    salmadent86@gmail.com   
Contact: Ghada Abd el-Monim, Phd    0201005113060    ghada.abdelmonim@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ghada abd el-monim, phd Cairo University
More Information
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Publications:

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Responsible Party: Salma Hassan Abd el-Aty, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03577210    
Other Study ID Numbers: Salma Hassan
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salma Hassan Abd el-Aty, Cairo University:
chin deficiency
chin asymmetry