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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039693
Receipt No. R000045263
Scientific Title Prevention of cardiovascular disease by improvement of life-style with oral health approach
Date of disclosure of the study information 2020/05/01
Last modified on 2021/09/04

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Basic information
Public title Prevention of cardiovascular disease by improvement of life-style with oral health approach
Acronym Prevention of cardiovascular disease by improvement of life-style with oral health approach
Scientific Title Prevention of cardiovascular disease by improvement of life-style with oral health approach
Scientific Title:Acronym Prevention of cardiovascular disease by improvement of life-style with oral health approach
Region
Japan

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

Objectives
Narrative objectives1 To assess an effect of life-style improvement via support by dental specialists on cardiovascular diseases.
Basic objectives2 Others
Basic objectives -Others To assess efficacy of dental intervention on medical parameters
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Onset of cardiovascular diseases
Key secondary outcomes Life-style, Dental parameters, Medical parameters

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Life-style improvements by lectures and health checkup in dentistry
Interventions/Control_2 Those who do not improve their life-style
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 Attendance of lectures
Key exclusion criteria Under 20 years old
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Norio
Middle name
Last name Aoyama
Organization Kanagawa Dental University
Division name Periodontology
Zip code 238-8580
Address Inaokacho 82, Yokosuka, Kanagawa, Japan
TEL 046-845-3160
Email aoyama@kdu.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Murakami
Organization Kanagawa Dental University
Division name Graduate Educational Research Department
Zip code 238-8580
Address Inaokacho 82, Yokosuka, Kanagawa, Japan
TEL 046-822-9690
Homepage URL
Email kenkyo@kdu.ac.jp

Sponsor
Institute Kanagawa Dental University
Institute
Department

Funding Source
Organization Kanagawa Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanagawa Dental University
Address Inaokacho 82, Yokosuka, Kanagawa, Japan
Tel 046-822-9690
Email murakami@kdu.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 神奈川歯科大学(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 01 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 Terminated
Date of protocol fixation
2020 Year 02 Month 25 Day
Date of IRB
2020 Year 02 Month 25 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
2024 Year 09 Month 30 Day
Date trial data considered complete
2024 Year 09 Month 30 Day
Date analysis concluded
2026 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 03 Month 04 Day
Last modified on
2021 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045263

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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