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
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
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
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
