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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03577210
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: augmentation genioplasty
 N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: computer-guided augmentation genioplasty

patient-specific PEEK implant

Procedure: augmentation genioplasty
augmentation genioplasty with patient-specific PEEK implant

Outcome Measures

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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Salma Hassan Cairo Egypt 21111

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Ghada abd el-monim, phd, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Salma Hassan Abd el-Aty, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT03577210
Other Study ID Numbers:
  • Salma Hassan
First Posted:
Jul 5, 2018
Last Update Posted:
Jul 5, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Assistant lecturer, Cairo University
chin deficiency
chin asymmetry

Study Results

No Results Posted as of Jul 5, 2018