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

Chin Microgenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577210
• Other study ID #: Salma Hassan
• Status: Recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: October 2019

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: salma h Abd el-Aty, MSc
• Phone: 0201113999772
• Email: salmadent[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chin Microgenia

Intervention

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

Locations

Country	Name	City	State
Egypt	Salma Hassan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Alonso-Rodriguez E, Cebrián JL, Nieto MJ, Del Castillo JL, Hernández-Godoy J, Burgueño M. Polyetheretherketone custom-made implants for craniofacial defects: Report of 14 cases and review of the literature. J Craniomaxillofac Surg. 2015 Sep;43(7):1232-8. doi: 10.1016/j.jcms.2015.04.028. Epub 2015 May 8. Review. — View Citation

Bertossi D, Galzignato PF, Albanese M, Botti C, Botti G, Nocini PF. Chin Microgenia: A Clinical Comparative Study. Aesthetic Plast Surg. 2015 Oct;39(5):651-8. doi: 10.1007/s00266-015-0518-4. Epub 2015 Jul 1. — View Citation

Hsu SS, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichgraeber JF, Zhou X, Xia JJ. Accuracy of a computer-aided surgical simulation protocol for orthognathic surgery: a prospective multicenter study. J Oral Maxillofac Surg. 2013 Jan;71(1):128-42. doi: 10.1016/j.joms.2012.03.027. Epub 2012 Jun 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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