UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032539 |
|---|---|
| Receipt number | R000037113 |
| Scientific Title | Development of fabrication of facial prostheses using three-dimensional additive manufacturing technology |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2023/05/16 11:30:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of fabrication of facial prostheses using three-dimensional additive manufacturing technology
Acronym
Development of fabrication of facial prostheses using 3D CAD/CAM technology
Scientific Title
Development of fabrication of facial prostheses using three-dimensional additive manufacturing technology
Scientific Title:Acronym
Development of fabrication of facial prostheses using 3D CAD/CAM technology
Region
| Japan |
Condition
Condition
Facial defect, Facial deformity
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop the methods for fabricating facial prostheses using three-dimensional CAD/CAM/additive manufacturing technology, without using facial impression method.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of 3D facial surface figures obtained by conventional facial impressions and optical scanner
Key secondary outcomes
Evaluation of color information obtained by optical scanner
Evaluation of facial prostheses accuracy printed by 3D CAD/CAM technology
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Facial and Optical impression
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects without any facial defects and/or deformity
Patients with facial defects and/or deformity
Key exclusion criteria
Those without consent to this study
Those with who are unable to express their intent
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Meiko |
| Middle name | |
| Last name | Oki |
Organization
Tokyo Medical and Dental University
Division name
Department of Basic Oral Health Engineering, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549 JAPAN
TEL
81-3-5803-5386
moki.mfoe@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Meiko |
| Middle name | |
| Last name | Oki |
Organization
Tokyo Medical and Dental University
Division name
Department of Basic Oral Health Engineering, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549 JAPAN
TEL
81-3-5803-5386
Homepage URL
moki.mfoe@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Oki Meiko
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549 JAPAN
Tel
03-5803-5406
d-hyoka.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
May 20, 2016, Date of re-IRB
July 23, 2018, Date of re-IRB
March 24, 2020, Date of re-IRB
Management information
Registered date
| 2018 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037113
