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

March 23, 2021 updated by: Mohamed Shawky, Cairo University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue effect
Time Frame: after one year
The impact of the interventions on the soft tissue gain after one year
after one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMFS 3-3-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

intervention and effect and demographic data

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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