UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039693 |
|---|---|
| Receipt number | 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 09:04:23 |
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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
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
kenkyo@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045263
