Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: A Pilot Study (3DJP16)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03057223|
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : March 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Mandibular Neoplasms Maxillary Neoplasms Dentofacial Deformities Maxillofacial Injuries||Device: 3D-printed patient-specific titanium plates||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label, prospective, single-arm, and single-center interventional clinical study.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: An Open-Label, Prospective Pilot Clinical Study|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: 3D Jaw Plate
3D Jaw Plate will be used in internal fixation.
Device: 3D-printed patient-specific titanium plates
3D-printed patient-specific titanium plates will be used in patients.
Other Name: 3D Jaw Plate
- 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.
- Incidence of postoperative adverse events [safety] [ Time Frame: 2-5 years postoperation ]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.
- Accuracy [ Time Frame: One and six months after surgery. ]The accuracy of using the 3D-printed customized titanium plates in transferring the virtual surgical plan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057223
|Contact: Yuxiong SU, Dr.||852 2859 firstname.lastname@example.org|
|Contact: Yiu Yan Leung, Dr.||852 9836 email@example.com|
|Principal Investigator:||Yuxiong SU, Dr.||The University of Hong Kong|