NCT04817930

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 21, 2021

Last Update Submit

March 23, 2021

Conditions

Chin Microgenia

Keywords

Chin microgeniaOrthognathic

Outcome Measures

Primary Outcomes (1)

  • soft tissue effect

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

    after one year

Study Arms (2)

Patient specific chin implant

EXPERIMENTAL

A patient specific chin peek implant was used for chin augmentation

Device: Polyetheretherketone patient specific implant

computer guided advancement genioplasty

EXPERIMENTAL

Computer guided advancement genioplasty using patient specific cutting and positioning guides

Device: Computer guided advancement genioplasty

Interventions

Polyetheretherketone patient specific implantDEVICE

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

Patient specific chin implant
Computer guided advancement genioplastyDEVICE

advancement genioplasty using patient specific cutting and positioning surgical stents

computer guided advancement genioplasty

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only
  • No prior surgery involving the chin

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Officials

  • Mohamed Shawky

    Assistant lecturer. OMFS. Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 26, 2021

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

intervention and effect and demographic data

Locations

EG(1)