The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency

July 3, 2018 updated by: Salma Hassan Abd el-Aty, Cairo University

The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study

computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.

Study Type

Interventional

Enrollment (Anticipated)

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male or female patients.
  • Patients with retruded chin or with chin asymmetry.
  • Patients with good oral hygiene.

Exclusion Criteria:

  • Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
  • Patients with medical condition that may compromise the healing process.
  • Patients with medical condition that is contraindicated for general anaesthesia.
  • Presence of pathological lesion related to chin area.

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: computer-guided augmentation genioplasty
patient-specific PEEK implant
Procedure: augmentation genioplasty
augmentation genioplasty with patient-specific PEEK implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
Time Frame: two weeks postoperative
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
two weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire
Time Frame: 6 months postoperative
degree of patient satisfaction using Face-Q questionnaire with score from 0-100 where 0 shows least degree of satisfaction and 100 shows best degree of satisfaction.
6 months postoperative

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Ghada abd el-monim, phd, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (ACTUAL)

July 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Salma Hassan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Chin Microgenia

Clinical Trials on augmentation genioplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe