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Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: A Pilot Study (3DJP16)

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ClinicalTrials.gov Identifier: NCT03057223
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Dr. Yuxiong Su, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Mandibular Neoplasms Maxillary Neoplasms Dentofacial Deformities Maxillofacial Injuries Device: 3D-printed patient-specific titanium plates Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Yuxiong SU, Dr. 852 2859 0267 richsu@hku.hk
Contact: Yiu Yan Leung, Dr. 852 9836 1107 mikeyyleung@hku.hk

Locations
Hong Kong
The Prince Philip Dental Hospital Recruiting
Hong Kong, Hong Kong, 000000
Contact: Yuxiong Su, Dr.    852 2859 0267    richsu@hku.hk   
Contact: Yiu Yan Leung, Dr.    852 9836 1107    mikeyyleung@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Chinese University of Hong Kong
Investigators
Principal Investigator: Yuxiong SU, Dr. The University of Hong Kong

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Yuxiong Su, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03057223     History of Changes
Other Study ID Numbers: UW 16-315
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Yuxiong Su, The University of Hong Kong:
3D printing
patient-specific titanium plate
mandibular malignancy
dento-maxillofacial deformity
orthognathic surgery
mandibular reconstruction

Additional relevant MeSH terms:
Neoplasms
Congenital Abnormalities
Dentofacial Deformities
Maxillofacial Injuries
Mandibular Neoplasms
Maxillary Neoplasms
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Jaw Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Jaw Diseases
Mandibular Diseases
Maxillary Diseases