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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04817930
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Chin Microgenia	Device: Polyetheretherketone patient specific implant; Device: Computer guided advancement genioplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient specific chin implant A patient specific chin peek implant was used for chin augmentation	Device: Polyetheretherketone patient specific implant; a customized peek patient specific implant is place to augment the chin
Experimental: computer guided advancement genioplasty Computer guided advancement genioplasty using patient specific cutting and positioning guides	Device: Computer guided advancement genioplasty; advancement genioplasty using patient specific cutting and positioning surgical stents

Outcome Measures

Primary Outcome Measures

1. soft tissue effect [after one year]

   The impact of the interventions on the soft tissue gain after one year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Mohamed Shawky, Assistant lecturer. OMFS. Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Shawky, Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up, Cairo University
• ClinicalTrials.gov Identifier: NCT04817930
• Other Study ID Numbers: OMFS 3-3-6
• First Posted: Mar 26, 2021
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• 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
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Mohamed Shawky, Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up, Cairo University: Chin microgenia; Orthognathic

Study Results

No Results Posted as of Mar 26, 2021