UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008270
Receipt number R000009749
Scientific Title A clinical study to discover the involvement of periodontal disease with circulative diseases
Date of disclosure of the study information 2012/07/01
Last modified on 2024/01/04 09:12:48

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Basic information

Public title

A clinical study to discover the involvement of periodontal disease with circulative diseases

Acronym

A clinical study to discover the involvement of periodontal disease with circulative diseases

Scientific Title

A clinical study to discover the involvement of periodontal disease with circulative diseases

Scientific Title:Acronym

A clinical study to discover the involvement of periodontal disease with circulative diseases

Region

Japan


Condition

Condition

Circulative 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

Basic objectives2

Others

Basic objectives -Others

relativity of diseases

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between periodontal disease and circulative diseases

Key secondary outcomes

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

Inpatients for circulative intervention at Cardiovascular Medicine, University Hospital of Medicine, Tokyo Medical and Dental University

Key exclusion criteria

Minor

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Mitsuaki
Middle name
Last name Isobe

Organization

Tokyo Medical and Dental University

Division name

Cardiovascular Medicine

Zip code

113-0034

Address

1-5-45, Yushima, Bunkyo city,Tokyo

TEL

03-5803-5951

Email

isobemi.cvm@tmd.ac.jp


Public contact

Name of contact person

1st name Jun-ichi
Middle name
Last name Suzuki

Organization

University of Tokyo

Division name

Advanced Clinical Science and Therapeutics

Zip code

113-0034

Address

7-3-1, Hongo, Bunkyo city, Tokyo

TEL

03-5800-9116

Homepage URL


Email

junichisuzuki-circ@umin.ac.jp


Sponsor or person

Institute

Cardiovascular Medicine, Tokyo Medical and Dental University

Institute

Department

Personal name



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

Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo, Tokyo

Tel

03-5803-5096

Email

Syomu1.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

東京医科歯科大学 医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 01 Day


Related information

URL releasing protocol

None

Publication of results

Published


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

1010

Results

Various findings were obtained regarding the relationship between periodontal disease and cardiovascular disease.

Results date posted

2024 Year 01 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Adults with cardiovascular disease

Participant flow

Recruited at Tokyo Medical and Dental University, Cardiovascular Medicine

Adverse events

None

Outcome measures

Periodontal disease index, cardiovascular disease index

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 04 Month 30 Day

Date of IRB

2012 Year 03 Month 12 Day

Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2015 Year 10 Month 01 Day

Date of closure to data entry

2015 Year 10 Month 01 Day

Date trial data considered complete

2015 Year 10 Month 01 Day

Date analysis concluded

2016 Year 09 Month 01 Day


Other

Other related information

To assess the relationship between periodontal disease and circulative diseases


Management information

Registered date

2012 Year 06 Month 26 Day

Last modified on

2024 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name