NCT03057223: 3DJP16

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

Completed NA Last updated 8 April 2021

What this trial tests

NA trial testing 3D-printed patient-specific titanium plates in Mandibular Neoplasms in 96 participants. Completed in 6 April 2021.

Timeline

1 September 2016

Primary endpoint
31 March 2021

6 April 2021

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	96
Start date	1 September 2016
Primary completion	31 March 2021
Estimated completion	6 April 2021
Sites	1 location across Hong Kong

Drugs / interventions tested

• 3D-printed patient-specific titanium plates

Conditions studied

• Mandibular Neoplasms — all drugs for Mandibular Neoplasms →
• Maxillary Neoplasms — all drugs for Maxillary Neoplasms →
• Dentofacial Deformities — all drugs for Dentofacial Deformities →
• Maxillofacial Injuries — all drugs for Maxillofacial Injuries →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Mandibular Neoplasms or Maxillary Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bone regeneration strategies: Engineered scaffolds, bioactive molecules and stem cells current stage and future perspectives.
   Ho-Shui-Ling A, Bolander J, Rustom LE, Johnson AW, et al · · 2018 · cited 606× · PMID 30036727 · DOI 10.1016/j.biomaterials.2018.07.017
2. Three-dimensional printing of patient-specific surgical plates in head and neck reconstruction: A prospective pilot study.
   Yang WF, Choi WS, Leung YY, Curtin JP, et al · · 2018 · cited 82× · PMID 29496055 · DOI 10.1016/j.oraloncology.2018.01.005
3. Three-Dimensionally Printed Patient-Specific Surgical Plates Increase Accuracy of Oncologic Head and Neck Reconstruction Versus Conventional Surgical Plates: A Comparative Study.
   Yang WF, Choi WS, Wong MC, Powcharoen W, et al · · 2021 · cited 55× · PMID 32572853 · DOI 10.1245/s10434-020-08732-y
4. A novel 'surgeon-dominated' approach to the design of 3D-printed patient-specific surgical plates in mandibular reconstruction: a proof-of-concept study.
   Yang WF, Zhang CY, Choi WS, Zhu WY, et al · · 2020 · cited 38× · PMID 31230767 · DOI 10.1016/j.ijom.2019.05.005
5. "One-piece" patient-specific reconstruction plate for double-barrel fibula-based mandibular reconstruction.
   Yang WF, Choi WS, Zhu WY, Su YX. · · 2020 · cited 14× · PMID 31892445 · DOI 10.1016/j.ijom.2019.12.006
6. A Comparative Study on a Novel Fibula Malleolus Cap to Increase the Accuracy of Oncologic Jaw Reconstruction.
   Pu JJ, Choi WS, Yeung WK, Yang WF, et al · · 2021 · cited 11× · PMID 35070962 · DOI 10.3389/fonc.2021.743389
7. The Learning Curve of Computer-Assisted Free Flap Jaw Reconstruction Surgery Using 3D-Printed Patient-Specific Plates: A Cumulative Sum Analysis.
   Zhu WY, Choi WS, Wong MCM, Pu JJ, et al · · 2021 · cited 9× · PMID 34604076 · DOI 10.3389/fonc.2021.737769
8. From the microspheres to scaffolds: advances in polymer microsphere scaffolds for bone regeneration applications.
   Yang S, Wu H, Peng C, He J, et al · · 2024 · cited 4× · PMID 39734699 · DOI 10.12336/biomatertransl.2024.03.005