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

Not Applicable

• Conditions: Chin Microgenia
• Interventions: Procedure: augmentation genioplasty

• Registration Number: NCT03577210
• Lead Sponsor: Cairo University

Brief Summary

computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.

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 Timeline

• Study First Submitted: 2018-05-16
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-03
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05
• Study Start: 2018-09
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
computer-guided augmentation genioplasty	augmentation genioplasty	patient-specific PEEK implant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Salma Hassan; 🇪🇬 Cairo, Egypt