Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up

Chin Microgenia Clinical Trial

Official title:

Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817930
• Other study ID #: OMFS 3-3-6
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only

• No prior surgery involving the chin

Exclusion Criteria:

• Patients whose clinical features revealed possible correction of their facial deformity using mandibular surgeries.

• Patients with systemic diseases that carried high risk for general anesthesia.

Related Conditions & MeSH terms

• Chin Microgenia

Intervention

Device:
• Polyetheretherketone patient specific implant
a customized peek patient specific implant is place to augment the chin
• Computer guided advancement genioplasty
advancement genioplasty using patient specific cutting and positioning surgical stents

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	soft tissue effect	The impact of the interventions on the soft tissue gain after one year	after one year