Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: A Pilot Study

NCT03057223 | Completed DMC

• 1 other identifier: UW 16-315
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Neoplasms; Maxillary Neoplasms; Dentofacial Deformities; Maxillofacial Injuries

Keywords

3D printing; patient-specific titanium plate; mandibular malignancy; dento-maxillofacial deformity; orthognathic surgery; mandibular reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of postoperative adverse events [safety]

  2-5 years postoperation

Other Outcomes (1)

• Accuracy

  One and six months after surgery.

Study Arms (1)

3D Jaw Plate

EXPERIMENTAL

3D Jaw Plate will be used in internal fixation.

Device: 3D-printed patient-specific titanium plates

Interventions

3D-printed patient-specific titanium plates DEVICE

3D-printed patient-specific titanium plates will be used in patients.

Also known as: 3D Jaw Plate

3D Jaw Plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 of either gender; and
• Signed informed consent form;and
• Single or double-jaw orthognathic surgery under general anaesthesia, or
• Jaw reconstruction due to benign or malignant tumor, osteomyelitis, and osteonecrosis under general anaesthesia.

You may not qualify if:

• Unstable or complicated systemic diseases that contraindicate the surgical process.
• Severe systemic diseases or conditions that would potentially compromise the healing process.
• Patients who are pregnant.
• Patients who are unable to take CT/CBCT scans.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

The Prince Philip Dental Hospital

Hong Kong, 000000, Hong Kong

Location

Related Publications (12)

• Martola M, Lindqvist C, Hanninen 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. doi: 10.1002/jbm.b.30603.

  PMID: 16850467 BACKGROUND

• 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.

  PMID: 26488900 BACKGROUND

• 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.

  PMID: 24987592 BACKGROUND

• Ventola CL. Medical Applications for 3D Printing: Current and Projected Uses. P T. 2014 Oct;39(10):704-11.

  PMID: 25336867 BACKGROUND

• Derand P, Rannar 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.

  PMID: 23997858 BACKGROUND

• 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.

  PMID: 22551671 BACKGROUND

• 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.

  PMID: 23714798 BACKGROUND

• 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.

  PMID: 25622881 BACKGROUND

• Yang WF, Choi WS, Wong MC, Powcharoen W, Zhu WY, Tsoi JK, Chow M, Kwok KW, Su YX. Three-Dimensionally Printed Patient-Specific Surgical Plates Increase Accuracy of Oncologic Head and Neck Reconstruction Versus Conventional Surgical Plates: A Comparative Study. Ann Surg Oncol. 2021 Jan;28(1):363-375. doi: 10.1245/s10434-020-08732-y. Epub 2020 Jun 22.

  PMID: 32572853 DERIVED

• Yang WF, Choi WS, Zhu WY, Su YX. "One-piece" patient-specific reconstruction plate for double-barrel fibula-based mandibular reconstruction. Int J Oral Maxillofac Surg. 2020 Aug;49(8):1016-1019. doi: 10.1016/j.ijom.2019.12.006. Epub 2019 Dec 28.

  PMID: 31892445 DERIVED

• Yang WF, Zhang CY, Choi WS, Zhu WY, Li DTS, Chen XS, Du R, Su YX. A novel 'surgeon-dominated' approach to the design of 3D-printed patient-specific surgical plates in mandibular reconstruction: a proof-of-concept study. Int J Oral Maxillofac Surg. 2020 Jan;49(1):13-21. doi: 10.1016/j.ijom.2019.05.005. Epub 2019 Jun 21.

  PMID: 31230767 DERIVED

• Yang WF, Choi WS, Leung YY, Curtin JP, Du R, Zhang CY, Chen XS, Su YX. Three-dimensional printing of patient-specific surgical plates in head and neck reconstruction: A prospective pilot study. Oral Oncol. 2018 Mar;78:31-36. doi: 10.1016/j.oraloncology.2018.01.005. Epub 2018 Jan 16.

  PMID: 29496055 DERIVED

MeSH Terms

Conditions

Mandibular Neoplasms; Maxillary Neoplasms; Dentofacial Deformities; Maxillofacial Injuries

Condition Hierarchy (Ancestors)

Jaw Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Mandibular Diseases; Stomatognathic Diseases; Maxillary Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Yuxiong SU, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: This is an open-label, prospective, single-arm, and single-center interventional clinical study.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: September 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: April 6, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

HK (1)