Mandibular Neoplasms3DJP16NCT03057223
Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: A Pilot Study
A study testing 3D-printed patient-specific titanium plates in people with Mandibular Neoplasms and Maxillary Neoplasms, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Neoplasms, Maxillary Neoplasms, Dentofacial Deformities
- What is being tested?
- 3D-printed patient-specific titanium plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2016to 6 Apr 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: An Open-Label, Prospective Pilot Clinical Study
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.
Read the detailed description
Plate osteosynthesis is the basic philosophy in maintaining skeletal stabilization in jaw surgery. Numerous branded osteosynthesis systems are available and most of them are made from pure titanium or titanium alloys with standard construction specifications. Usually these titanium plates should be bended and arched to better match the three-dimensional contour of anchored jaw bones. However the optimal bending of the titanium plate sometimes is difficult and time-consuming especially for the inexperienced surgeons and in complicated cases. Excessive bending could also initiate residual stress and potentially worsen the mechanical properties of titanium plates(1).
The three-dimensional (3D) printing, or additive manufacturing, has been well developed in fabricating customized materials from the computer-generated digital files. In recent years, 3D printing of patient-specific medical implants has been evolving with the newly-emerged technology of powder bed fusion, which enabled the melting of metals and further shaping of devices(2). In September 2015, China's innovative 3D printed hip joint prosthesis was commercially certified by China's State Food and Drug Administration. In February 2016, the world's first 3D printed patient-specific titanium cranial/craniofacial plate implant got the U.S. Food and Drug Administration's approval. Beyond that, a number of other printed implants have showed excellent performance in clinical research. These printed medical implants are majorly from pure titanium or Ti6Al4V alloy, which exhibit good resistance to fatigue and corrosion and are considered the most biocompatible metal(3). Relying on individualized imaging data, the printed implants are patient-specific and adapt to the anatomical structures precisely. Since the additive manufacturing is ultimately different from the conventional multi-step production operations, it could reduce costs and lead times, especially in printing complex devices for individualized cases. While in clinical applications, 3D printing of customized implants are expected to facilitate surgical operation, reduce application duration and improve precise restoration(4). It is predicted the application of 3D printing technique in medical area may bring forward another major advance toward personalized medicine(5). Many more customized medical implants will be approved in the future across the world.
With the advent of metal additive manufacturing, the 3D-printed patient-specific titanium plates have been successfully fabricated. In 2012, Per Derand et al. reported the first application of 3D-printed titanium plates with the established workflow from imaging, via virtual design, to manufacturing of cutting guide and customized titanium reconstruction plates, and its utility in the fibula-based mandibular reconstruction surgery. The pre-printed plates did facilitate the operation and reduced the operation duration about half an hour though the postoperative accuracy of the grafted bone was modest compared with the virtual planning(6). Simultaneously, Leonardo Ciocca et al. reported the computer-aided designing and manufacturing in guiding secondary mandibular reconstruction of a discontinuity defect involving the employment of the surgical guide and printed titanium reconstruction plate in surgical transferring of virtual planning(7). In 2013, Simona Mazzoni and Leonardo Ciocca et al. applied the same surgical protocol in a study group of seven mandibular reconstruction patients and compared its advantages with the standard pre-plating technique on stereolithographic models in a control group. The results revealed the computer-aided surgical protocol was viable in reproducing the patients' anatomical contour, giving the surgeon better procedural control and reducing procedure time(8). In 2015, Simona Mazzoni et al. further developed the computer-aided designing and manufacturing technique in fabricating surgical cutting guides and titanium fixation plates in upper maxilla repositioning surgery without an occlusal wafer. The study result confirmed the high accuracy in transferring the virtual planning by using the surgical guides and fixation plates(9).
In reviewing the literature, the application of 3D printing of titanium fixation plates in jaw surgery are available only at two centers currently: the Maxillofacial Surgery Department of S Orsola Malpighi Hospital in Italy and the Oral and Maxillofacial Surgery Department of Lund University in Sweden(6,7). The published preliminary work have proved the prospect of 3D-printed 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 3D printing in health care, we will develop a new designing and manufacturing protocol in printing customized fixation plates, which will be designed in specific loading circumstances and will perfectly adapt to the anatomical structures of the jaw. It is imperative to conduct a feasibility study in exploring the application of 3D printing of titanium fixation plates in jaw surgery based on our patients.
- Conditions
- Mandibular Neoplasms, Maxillary Neoplasms, Dentofacial Deformities, Maxillofacial Injuries
- Being tested
- 3D-printed patient-specific titanium plates
- Keywords
- 3D printing, patient-specific titanium plate, mandibular malignancy, dento-maxillofacial deformity, orthognathic surgery, mandibular reconstruction
- Medical subject headings
- Mandibular Neoplasms, Maxillary Neoplasms, Dentofacial Deformities, Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed patient-specific titanium platesDevice
Also called 3D Jaw Plate
3D-printed patient-specific titanium plates will be used in patients.
| Study group | Role | What they receive |
|---|---|---|
| 3D Jaw Plate | Experimental | 3D Jaw Plate will be used in internal fixation. Receives: Device: 3D-printed patient-specific titanium plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative success rate
- 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.
Measured: Intraoperation
Secondary outcomes (1)
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.
Measured: 2-5 years postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Sep 2016
- Primary completion31 Mar 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mandibular NeoplasmsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, prospective, single-arm, and single-center interventional clinical study.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. Yuxiong Su, The University of Hong Kong
- Investigators
- Yuxiong SU, Dr., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057223
- Sponsor's protocol ID
- UW 16-315
- Acronym
- 3DJP16
- Status last verified
- Apr 2021
- First submitted
- 15 Feb 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16850467Sing 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.
PubMed 26488900Parthasarathy 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.
PubMed 24987592Ventola CL. Medical Applications for 3D Printing: Current and Projected Uses. P T. 2014 Oct;39(10):704-11.
PubMed 25336867Derand 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.
PubMed 23997858Ciocca 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.
PubMed 22551671Mazzoni 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.
PubMed 23714798Mazzoni 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.
PubMed 25622881Yang 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.
PubMed 32572853Yang 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.
PubMed 31892445Yang 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.
PubMed 31230767Yang 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.
PubMed 29496055
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: An Open-Label, Prospective Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT03057223
- Acronym / sponsor ID
- 3DJP16 / UW 16-315
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 20 Feb 2017 (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.
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.
Detailed description
Plate osteosynthesis is the basic philosophy in maintaining skeletal stabilization in jaw surgery. Numerous branded osteosynthesis systems are available and most of them are made from pure titanium or titanium alloys with standard construction specifications. Usually these titanium plates should be bended and arched to better match the three-dimensional contour of anchored jaw bones. However the optimal bending of the titanium plate sometimes is difficult and time-consuming especially for the inexperienced surgeons and in complicated cases. Excessive bending could also initiate residual stress and potentially worsen the mechanical properties of titanium plates(1).
The three-dimensional (3D) printing, or additive manufacturing, has been well developed in fabricating customized materials from the computer-generated digital files. In recent years, 3D printing of patient-specific medical implants has been evolving with the newly-emerged technology of powder bed fusion, which enabled the melting of metals and further shaping of devices(2). In September 2015, China's innovative 3D printed hip joint prosthesis was commercially certified by China's State Food and Drug Administration. In February 2016, the world's first 3D printed patient-specific titanium cranial/craniofacial plate implant got the U.S. Food and Drug Administration's approval. Beyond that, a number of other printed implants have showed excellent performance in clinical research. These printed medical implants are majorly from pure titanium or Ti6Al4V alloy, which exhibit good resistance to fatigue and corrosion and are considered the most biocompatible metal(3). Relying on individualized imaging data, the printed implants are patient-specific and adapt to the anatomical structures precisely. Since the additive manufacturing is ultimately different from the conventional multi-step production operations, it could reduce costs and lead times, especially in printing complex devices for individualized cases. While in clinical applications, 3D printing of customized implants are expected to facilitate surgical operation, reduce application duration and improve precise restoration(4). It is predicted the application of 3D printing technique in medical area may bring forward another major advance toward personalized medicine(5). Many more customized medical implants will be approved in the future across the world.
With the advent of metal additive manufacturing, the 3D-printed patient-specific titanium plates have been successfully fabricated. In 2012, Per Derand et al. reported the first application of 3D-printed titanium plates with the established workflow from imaging, via virtual design, to manufacturing of cutting guide and customized titanium reconstruction plates, and its utility in the fibula-based mandibular reconstruction surgery. The pre-printed plates did facilitate the operation and reduced the operation duration about half an hour though the postoperative accuracy of the grafted bone was modest compared with the virtual planning(6). Simultaneously, Leonardo Ciocca et al. reported the computer-aided designing and manufacturing in guiding secondary mandibular reconstruction of a discontinuity defect involving the employment of the surgical guide and printed titanium reconstruction plate in surgical transferring of virtual planning(7). In 2013, Simona Mazzoni and Leonardo Ciocca et al. applied the same surgical protocol in a study group of seven mandibular reconstruction patients and compared its advantages with the standard pre-plating technique on stereolithographic models in a control group. The results revealed the computer-aided surgical protocol was viable in reproducing the patients' anatomical contour, giving the surgeon better procedural control and reducing procedure time(8). In 2015, Simona Mazzoni et al. further developed the computer-aided designing and manufacturing technique in fabricating surgical cutting guides and titanium fixation plates in upper maxilla repositioning surgery without an occlusal wafer. The study result confirmed the high accuracy in transferring the virtual planning by using the surgical guides and fixation plates(9).
In reviewing the literature, the application of 3D printing of titanium fixation plates in jaw surgery are available only at two centers currently: the Maxillofacial Surgery Department of S Orsola Malpighi Hospital in Italy and the Oral and Maxillofacial Surgery Department of Lund University in Sweden(6,7). The published preliminary work have proved the prospect of 3D-printed 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 3D printing in health care, we will develop a new designing and manufacturing protocol in printing customized fixation plates, which will be designed in specific loading circumstances and will perfectly adapt to the anatomical structures of the jaw. It is imperative to conduct a feasibility study in exploring the application of 3D printing of titanium fixation plates in jaw surgery based on our patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, prospective, single-arm, and single-center interventional clinical study.
| Arm | Type | Receives |
|---|---|---|
| 3D Jaw Plate | Experimental | Device: 3D-printed patient-specific titanium plates3D Jaw Plate will be used in internal fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 patient-specific titanium platesAlso: 3D Jaw Plate3D-printed patient-specific titanium plates will be used in patients. | Device | 3D Jaw Plate |
Primary outcome
Intraoperative success rate
Time frame: Intraoperation
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.
1 secondary outcome
Incidence of postoperative adverse events [safety]
Time frame: 2-5 years postoperation
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 8 Apr 2021.
- Background: PubMed 16850467Martola 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.
- Background: PubMed 26488900Sing 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.
- Background: PubMed 24987592Parthasarathy 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.
- Background: PubMed 25336867Ventola CL. Medical Applications for 3D Printing: Current and Projected Uses. P T. 2014 Oct;39(10):704-11.
- Background: PubMed 23997858Derand 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.
- Background: PubMed 22551671Ciocca 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.
- Background: PubMed 23714798Mazzoni 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.
- Background: PubMed 25622881Mazzoni 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.
- Derived from this study: PubMed 32572853Yang 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.
- Derived from this study: PubMed 31892445Yang 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.
- Derived from this study: PubMed 31230767Yang 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.
- Derived from this study: PubMed 29496055Yang 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.
- 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.
Yuxiong SU, Dr. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed patient-specific titanium plates in people with Mandibular Neoplasms and Maxillary Neoplasms, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 4 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 8 Apr 2021. 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 Hong Kong. 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?
Intraoperative success rate (time frame: Intraoperation). 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 NCT03057223, which also lists 12 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 8 Apr 2021.