Mucormycosis Clinical Trial
Official title:
Evaluation of Using 3D Printed Polyether Ether Ether Ketone Facial Implants in Repairing Maxillofacial Deformities
Verified date | April 2022 |
Source | Tishreen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 .
Status | Completed |
Enrollment | 10 |
Est. completion date | April 10, 2022 |
Est. primary completion date | March 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Tishreen university | Latakia |
Lead Sponsor | Collaborator |
---|---|
Tishreen University |
Syrian Arab Republic,
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). pii: 4046. doi: 10.3390/polym13224046. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
after 3 months of the surgical procedure | |
Primary | 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 |
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