Evaluation of Using 3D Printed PEEK Facial Implants in Repairing Maxillofacial Deformities

April 20, 2022 updated by: Tishreen University

Evaluation of Using 3D Printed Polyether Ether Ether Ketone Facial Implants in Repairing Maxillofacial Deformities

Objective: Evaluation of using 3D printed polyether ether ketone facial implants in repairing maxillofacial deformities.

Research materials and methods: The research sample consisted of 10 patients with facial deformities (maxillofacial trauma patients with hard tissue deficiencies, tumor patients who had previous facial surgery, patients have retrognathia, congenital malformation, patients with hemifacial microsomia - bone loss as a result of a mucormycotic infection or black fungus ) Between 2020 and 2021 in the Department of Oral and Maxillofacial Surgery in the Tishreen University Hospital - Latakia - Syria. All patients underwent Computed Tomography (CT) scans under the condition of providing a large number of slices (more than 200 slices) per axis, and the thickness of each slice is less than 1 mm with 64-bit resolution, Then the design of the required facial implant was carried out in coordination between the designer and the surgical team. The final form of the facial implant was printed from PolyEther Ether Ketone (PEEK), and then surgical work was performed for patients under general anaesthetic according to the appropriate surgical entrance. The implants were fixed in place using titanium screws and the patients were given appropriate pharmacological coverage .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

10 patients with maxillofacial deformities (trauma patients, war injuries, patients with pre-existing maxillofacial tumours, and mucormycotic patients) for reconstruction with 3D printed facial implants made of PEEK, between 2020 and 2021 in the Department of Oral and maxillofacial Surgery at the Tishreen University Hospital, Latakia, Syria. All patients underwent three-axial CT scan using a Toshiba Slice CT Scanner-Imaging, under the condition of providing a large number of slices (more than 200 slices) per axis, and the thickness of each slice is less than 1 mm with 64-bit resolution. Representative models of patient anatomical data were created based on the radiated raw data of the patient obtained via Digital Imaging and Communications in Medicine (DICOM) from the CT scan. The DICOM format is 0.3 to 0.6 mm thick, depending on the anatomical region. The medical modelling software (EXoCad) was used to compile DICOM data at the axial, sagittal, and coronal planes and then create a 3D virtual model of the anatomical region.

The surgeon and the manufacturing technician met to discuss the design format and any modifications required, with the proposed areas for placement of the titanium screws for the installation of the facial implant. The final default model for the facial implant was exported as a STereoLithography (STL) file and sent to the 3D printer, which was eventually made for the patient. The printer used in our study is a prototype of OO-Kuma Katana HT PEEK 3D Printer. After the process of printing, the facial implant is steam sterilized and then the implant is encapsulated. The surgical work of the patients was performed under general anaesthesia at the Tishreen University Hospital, Latakia, Syria, at the appropriate surgical entrance depending on the size and location of the deformity. The facial implant was checked to be suitable before stabilization and the required modifications were made during the process. The PSI was fixed in place using 1.5 to 2.0mm sized titanium screws, all patients received an intravenous 1.2g Augmentin dose and 0.5g of Flagyl during the procedure. After the surgery, patients received two doses of Augmentin, after which a prescription of Augmentin 1g and Flagyl 0.5g orally per day for a week was given.

Study Type

Observational

Enrollment (Actual)

10

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 to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with facial deformities at the Oral and Maxillofacial department of Tishreen University Hospital

Description

Inclusion Criteria:

- patients with facial deformities:

  1. maxillofacial trauma patients with hard tissue deficiencies
  2. tumor patients who had previous facial surgery
  3. patients have retrognathia
  4. congenital malformation
  5. patients with hemifacial microsomia
  6. bone loss as a result of a mucormycotic infection or black fungus

Exclusion Criteria:

  1. acute stage oncology patients
  2. There is not enough soft tissue to cover the facial implants

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with maxillofacial deformities
10 patients with maxillofacial deformities (trauma patients, war injuries, patients with pre-existing maxillofacial tumours, and meucrmycotic patients)
Procedure: 3D printed polyether ether ketone facial implants in repairing maxillofacial deformities
All patients underwent Computed Tomography (CT) scans under the condition of providing a large number of slices (more than 200 slices) per axis, and the thickness of each slice is less than 1 mm with 64-bit resolution, Then the design of the required facial implant was carried out in coordination between the designer and the surgical team. The final form of the facial implant was printed from PolyEther Ether Ketone (PEEK), and then surgical work was performed for patients under general anaesthetic according to the appropriate surgical entrance. The implants were fixed in place using titanium screws
Other Names:
  • PSI PEEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Cosmetic patients' satisfaction level .
Time Frame: after 3 months of the surgical procedure

Three months after the surgery, we asked the patient to evaluate the aesthetic result by choosing a number from 1 to 5 , as 5 is the best cosmetic result.

satisfaction scale :

  1. bad
  2. medium
  3. neutral
  4. satisfied
  5. very satisfied
after 3 months of the surgical procedure
Evaluation of infection after using 3D printed polyetheretherketone facial implants in repair of maxillofacial deformities
Time Frame: after surgical procedure a week, one month and three months

A doctor _not included in the research team_ performed clinical examinations of patients after surgical procedure a week, one month and three months to check for clinical signs of infection .

  • When there are signs of infection, he records the number 1 .
  • When there are no signs of infection, he records the number 0 .
after surgical procedure a week, one month and three months

Collaborators and Investigators

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

Sponsor

Tishreen University

Investigators

  • Study Chair: Hekmat Yacoub, PHD, Tishreen University
  • Study Director: Ali Khalil, PHD, Tishreen University
  • Principal Investigator: Ahmad Ahmad, Master, Tishreen 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 (Actual)

February 25, 2020

Primary Completion (Actual)

March 5, 2022

Study Completion (Actual)

April 10, 2022

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tishreen U- Maxillofacial sur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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