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

NCT ID: NCT04817930

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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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

Detailed Description

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Conditions

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Chin Microgenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Patient specific chin implant

A patient specific chin peek implant was used for chin augmentation

Group Type EXPERIMENTAL

Polyetheretherketone patient specific implant

Intervention Type DEVICE

a customized peek patient specific implant is place to augment the chin

computer guided advancement genioplasty

Computer guided advancement genioplasty using patient specific cutting and positioning guides

Group Type EXPERIMENTAL

Computer guided advancement genioplasty

Intervention Type DEVICE

advancement genioplasty using patient specific cutting and positioning surgical stents

Interventions

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Polyetheretherketone patient specific implant

a customized peek patient specific implant is place to augment the chin

Intervention Type DEVICE

Computer guided advancement genioplasty

advancement genioplasty using patient specific cutting and positioning surgical stents

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Shawky

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Shawky

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer. OMFS. Cairo University

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OMFS 3-3-6

Identifier Type: -

Identifier Source: org_study_id

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