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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032794
Receipt No. R000037410
Scientific Title Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Date of disclosure of the study information 2019/03/31
Last modified on 2018/06/01

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Basic information
Public title Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Acronym Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Scientific Title Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Scientific Title:Acronym Invention and application for clinical diagnosis of dental OCT (optical coherence tomography)
Region
Japan

Condition
Condition caries
restorative material
endodontitis
periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Invent and innovate dental OCT to clinical dentistry.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes degree of caries progression
gap, fracture state
pulp chamber
shape of periodontal tissue
Key secondary outcomes

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Introduction of new diagnosis device in dental treatment.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Any patient who provides consent.
Key exclusion criteria Patients who don't provide consent.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Tagami
Organization Tokyo Medial and Dental University
Division name Cariology and Operative Dentistry
Zip code
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 03-5803-5483
Email tagami.ope@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Tagami
Organization Tokyo Medial and Dental University
Division name Cariology and Operative Dentistry
Zip code
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 03-5803-5483
Homepage URL
Email tagami.ope@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
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
Address
Tel
Email

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
2019 Year 03 Month 31 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
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 Preinitiation
Date of protocol fixation
2010 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 08 Day
Last follow-up date
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 30 Day
Last modified on
2018 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037410

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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