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

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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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name