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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017027
Receipt No. R000019746
Scientific Title A clinical study to discover the involvement of periodontal disease with circulative diseases in Japan and Asian countries
Date of disclosure of the study information 2015/04/02
Last modified on 2018/03/12

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Basic information
Public title A clinical study to discover the involvement of periodontal disease with circulative diseases in Japan and Asian countries
Acronym A clinical study to discover the involvement of periodontal disease with circulative diseases in Japan and Asian countries
Scientific Title A clinical study to discover the involvement of periodontal disease with circulative diseases in Japan and Asian countries
Scientific Title:Acronym A clinical study to discover the involvement of periodontal disease with circulative diseases in Japan and Asian countries
Region
Japan Asia(except Japan)

Condition
Condition Cardiovascular diseases, Periodontal disease
Classification by specialty
Cardiology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the involvement of periodontal condition and periodontal bacteria with some circulative diseases by international comparison
Basic objectives2 Others
Basic objectives -Others relativity of diseases
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes International difference of correlation between periodontal disease and circulative diseases
Key secondary outcomes International difference of correlation between periodontal bacteria and circulative diseases

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients for circulative intervention at Tokyo Medical and Dental University Hospital, hospitals in Beijing, China and hospitals in Bangkok, Thailand
Key exclusion criteria Minor
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun-ichi Suzuki
Organization the University of Tokyo
Division name Advanced Clinical Sciense and Therapeutics
Zip code
Address 7-3-1 Hongo, Bunkyo, Tokyo
TEL 03-5800-9116
Email junichisuzuki-circ@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Aoyama
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address 1-5-45 Yushima, Bunkyo, Tokyo
TEL 03-5803-5488
Homepage URL
Email aoyama@kdu.ac.jp

Sponsor
Institute Advanced Clinical Sciense and Therapeutics, the University of Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 東京医科歯科大学 医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 02 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 02 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information To assess the relationship between periodontal disease and circulative diseases

Management information
Registered date
2015 Year 04 Month 02 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019746

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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