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

NCT05348434 | Completed DMC

• 1 other identifier: Tishreen U- Maxillofacial sur
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Maxillofacial Trauma; Face Cancer; Mucormycosis

Keywords

facial implant; 3d printing; polyetheretherketone

Outcome Measures

Primary Outcomes (2)

• Evaluation of Cosmetic patients' satisfaction level .

  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

  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

Study Arms (1)

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

Interventions

3D printed polyether ether ketone facial implants in repairing maxillofacial deformities PROCEDURE

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

Also known as: PSI PEEK

patients with maxillofacial deformities

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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

You may not qualify if:

• acute stage oncology patients
• There is not enough soft tissue to cover the facial implants

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen university

Latakia, Syria

Location

Related Publications (3)

• Dua R, Rashad Z, Spears J, Dunn G, Maxwell M. Applications of 3D-Printed PEEK via Fused Filament Fabrication: A Systematic Review. Polymers (Basel). 2021 Nov 22;13(22):4046. doi: 10.3390/polym13224046.

  PMID: 34833346 RESULT

• Kang J, Zhang J, Zheng J, Wang L, Li D, Liu S. 3D-printed PEEK implant for mandibular defects repair - a new method. J Mech Behav Biomed Mater. 2021 Apr;116:104335. doi: 10.1016/j.jmbbm.2021.104335. Epub 2021 Jan 21.

  PMID: 33494021 RESULT

• Panayotov IV, Orti V, Cuisinier F, Yachouh J. Polyetheretherketone (PEEK) for medical applications. J Mater Sci Mater Med. 2016 Jul;27(7):118. doi: 10.1007/s10856-016-5731-4. Epub 2016 Jun 3.

  PMID: 27259708 RESULT

MeSH Terms

Conditions

Mucormycosis

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Hekmat Yacoub, PHD

  Tishreen University

  STUDY CHAIR

• Ali Khalil, PHD

  Tishreen University

  STUDY DIRECTOR

• Ahmad Ahmad, Master

  Tishreen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 27, 2022
• Study Start: February 25, 2020
• Primary Completion: March 5, 2022
• Study Completion: April 10, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

SY (1)