Dentofacial Deformities Clinical Trial
— 3DJP16Official title:
Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: An Open-Label, Prospective Pilot Clinical Study
Verified date | April 2021 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Medical titanium plates are routinely used in fixing mobilized bone segments in jaw surgeries. Generally these plates are commercialized with standard construction specifications. Thus they should be repeatedly bended and arched to match the contour of anchored jaw bones before located in place and fastened by screws. To prevent stress fatigue induced by plate bending and improve structural design, we utilized the three-dimensional printing technique and developed a new production procedure in fabricating customized titanium plates according to each patient's specific skeletal contours and dimensions derived from medical imaging data. In general, the three-dimensional printing of customized implants are expected to facilitate surgical operation, reduce application duration and improve precise restoration. Up until now, the application of three-dimensional printing of titanium fixation plates in jaw surgery has been available only at two centers globally. The published preliminary work have proved the prospect of customized titanium plates in promoting mandibular reconstruction surgery and upper maxilla orthognathic surgery though their printed titanium plates looked rather bulky and the sample sizes were small and there is still lack of qualified randomized controlled trials between the printed and the conventional titanium plates. To better benefit from the burgeoning use of three-dimensional printing in health care, it is imperative to conduct a feasibility study in exploring the application of three-dimensional printing of titanium fixation plates in jaw surgery based on our patients. The aim of the study is to conduct a case series study focusing on the feasibility and safety of applying three-dimensional printed titanium plates in jaw reconstruction surgery and orthognathic surgery. The outcome measures include the success rate, potential adverse events and accuracy. A sample size of 48 subjects will be recruited prospectively. Considering the facts that titanium plates are widely used in jaw surgery and our unit is the largest oral and maxillofacial surgery center in Hong Kong, the well-designed customized titanium plate is therefore with great potential benefit for the patients in our population. Furthermore, the well-developed three-dimensional manufacturing protocol could also be applied in other relevant medical areas and push forward the personalized medicine era in the future.
Status | Completed |
Enrollment | 96 |
Est. completion date | April 6, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age greater than 18 of either gender; and 2. Signed informed consent form;and 3. Single or double-jaw orthognathic surgery under general anaesthesia, or 4. Jaw reconstruction due to benign or malignant tumor, osteomyelitis, and osteonecrosis under general anaesthesia. Exclusion Criteria: 1. Unstable or complicated systemic diseases that contraindicate the surgical process. 2. Severe systemic diseases or conditions that would potentially compromise the healing process. 3. Patients who are pregnant. 4. Patients who are unable to take CT/CBCT scans. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Prince Philip Dental Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Chinese University of Hong Kong |
Hong Kong,
Ciocca L, Mazzoni S, Fantini M, Persiani F, Marchetti C, Scotti R. CAD/CAM guided secondary mandibular reconstruction of a discontinuity defect after ablative cancer surgery. J Craniomaxillofac Surg. 2012 Dec;40(8):e511-5. doi: 10.1016/j.jcms.2012.03.015. Epub 2012 Apr 30. — View Citation
Dérand P, Rännar LE, Hirsch JM. Imaging, virtual planning, design, and production of patient-specific implants and clinical validation in craniomaxillofacial surgery. Craniomaxillofac Trauma Reconstr. 2012 Sep;5(3):137-44. doi: 10.1055/s-0032-1313357. — View Citation
Martola M, Lindqvist C, Hänninen H, Al-Sukhun J. Fracture of titanium plates used for mandibular reconstruction following ablative tumor surgery. J Biomed Mater Res B Appl Biomater. 2007 Feb;80(2):345-52. — View Citation
Mazzoni S, Bianchi A, Schiariti G, Badiali G, Marchetti C. Computer-aided design and computer-aided manufacturing cutting guides and customized titanium plates are useful in upper maxilla waferless repositioning. J Oral Maxillofac Surg. 2015 Apr;73(4):701-7. doi: 10.1016/j.joms.2014.10.028. Epub 2014 Nov 29. — View Citation
Mazzoni S, Marchetti C, Sgarzani R, Cipriani R, Scotti R, Ciocca L. Prosthetically guided maxillofacial surgery: evaluation of the accuracy of a surgical guide and custom-made bone plate in oncology patients after mandibular reconstruction. Plast Reconstr Surg. 2013 Jun;131(6):1376-1385. doi: 10.1097/PRS.0b013e31828bd6b0. — View Citation
Parthasarathy J. 3D modeling, custom implants and its future perspectives in craniofacial surgery. Ann Maxillofac Surg. 2014 Jan;4(1):9-18. doi: 10.4103/2231-0746.133065. Review. — View Citation
Sing SL, An J, Yeong WY, Wiria FE. Laser and electron-beam powder-bed additive manufacturing of metallic implants: A review on processes, materials and designs. J Orthop Res. 2016 Mar;34(3):369-85. doi: 10.1002/jor.23075. Epub 2015 Oct 29. Review. — View Citation
Ventola CL. Medical Applications for 3D Printing: Current and Projected Uses. P T. 2014 Oct;39(10):704-11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accuracy | The accuracy of using the 3D-printed customized titanium plates in transferring the virtual surgical plan. | One and six months after surgery. | |
Primary | Intraoperative success rate | 1) the uneventful application of the 3D-printed patient-specific titanium plate in jaw surgery without any minor revision; 2) the final restored outcome being optimal based on clinical parameters. | Intraoperation | |
Secondary | Incidence of postoperative adverse events [safety] | An adverse event is defined as any untoward medical occurrence in a patient administered the 3D-printed patient-specific titanium plate, which may or may not necessarily have a causal relationship with this new device. | 2-5 years postoperation |
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