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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032539
Receipt No. 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 2019/05/14

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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
Email 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
Email moki.mfoe@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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
Email 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 Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 12 Day
Date of IRB
2018 Year 07 Month 23 Day
Anticipated trial start date
2015 Year 04 Month 27 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 10 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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