Maxillofacial TraumaNCT05348434
Evaluation of Using 3D Printed PEEK Facial Implants in Repairing Maxillofacial Deformities
An observational study of Maxillofacial Trauma and Face Cancer, run by Latakia University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Trauma, Face Cancer, Mucormycosis
- What is being tested?
- 3D printed polyether ether ketone facial implants in repairing maxillofacial deformities
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSyria
- Study dates
- 25 Feb 2020to 10 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients diagnosed with facial deformities at the Oral and Maxillofacial department of Tishreen University Hospital
Who may be able to join
- 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
Who cannot join
- acute stage oncology patients
- There is not enough soft tissue to cover the facial implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Maxillofacial Trauma, Face Cancer, Mucormycosis
- Being tested
- 3D printed polyether ether ketone facial implants in repairing maxillofacial deformities
- Keywords
- facial implant, 3d printing, polyetheretherketone
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed polyether ether ketone facial implants in repairing maxillofacial deformitiesProcedure or surgery
Also called PSI PEEK
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
| Study group | Role | What they receive |
|---|---|---|
| patients with maxillofacial deformities | 10 patients with maxillofacial deformities (trauma patients, war injuries, patients with pre-existing maxillofacial tumours, and meucrmycotic patients) Receives: Procedure: 3D printed polyether ether ketone facial implants in repairing maxillofacial deformities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 :
- bad
- medium
- neutral
- satisfied
- very satisfied
Measured: 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 .
Measured: after surgical procedure a week, one month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start25 Feb 2020
- Primary completion5 Mar 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hekmat Yacoub, PHD, Study chair, Latakia UniversityAli Khalil, PHD, Study director, Latakia UniversityAhmad Ahmad, Master, Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348434
- Sponsor's protocol ID
- Tishreen U- Maxillofacial sur
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34833346Kang 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.
PubMed 33494021Panayotov 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.
PubMed 27259708
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using 3D Printed Polyether Ether Ether Ketone Facial Implants in Repairing Maxillofacial Deformities
- ClinicalTrials.gov ID
- NCT05348434
- Acronym / sponsor ID
- Tishreen U- Maxillofacial sur
- Conditions
- Maxillofacial Trauma, Face Cancer, Mucormycosis
- Keywords
- facial implant, 3d printing, polyetheretherketone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with maxillofacial deformities | – | Procedure: 3D printed polyether ether ketone facial implants in repairing maxillofacial deformities10 patients with maxillofacial deformities (trauma patients, war injuries, patients with pre-existing maxillofacial tumours, and meucrmycotic patients) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with facial deformities at the Oral and Maxillofacial department of Tishreen University Hospital
Key inclusion criteria (7 listed)
- patients with facial deformities:
- maxillofacial trauma patients with hard tissue deficiencies
- tumor patients who had previous facial surgery
- patients have retrognathia
- congenital malformation
Key exclusion criteria (2 listed)
- acute stage oncology patients
- There is not enough soft tissue to cover the facial implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed polyether ether ketone facial implants in repairing maxillofacial deformitiesAlso: PSI PEEKAll 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 | Procedure or surgery | patients with maxillofacial deformities |
Primary outcome
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
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Results publication: PubMed 34833346Dua 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.
- Results publication: PubMed 33494021Kang 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.
- Results publication: PubMed 27259708Panayotov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hekmat Yacoub, PHD study chair
Latakia University
Ali Khalil, PHD study director
Latakia University
Ahmad Ahmad, Master principal investigator
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Trauma and Face Cancer, run by Latakia University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Cosmetic patients' satisfaction level . (time frame: after 3 months of the surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348434, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.