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

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

Detailed Description
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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.

Official Title
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The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study

Conditions
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Chin Microgenia

Intervention / Treatment
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* Procedure: augmentation genioplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: computer-guided augmentation genioplasty<br>patient-specific PEEK implant | Procedure: augmentation genioplasty<br>* augmentation genioplasty with patient-specific PEEK implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm | degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm | two weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire | 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. | 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chin deficiency, chin asymmetry