UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018500 |
|---|---|
| Receipt number | R000021408 |
| Scientific Title | Evaluation of the effectiveness of dental health instructions for preventing lifestyle-related diseases of adults with metabolic syndrome or pre metabolic syndrome. : A pilot intervention study. |
| Date of disclosure of the study information | 2015/08/07 |
| Last modified on | 2020/08/20 18:12:18 |
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Basic information
Public title
Evaluation of the effectiveness of dental health instructions for preventing lifestyle-related diseases of adults with metabolic syndrome or pre metabolic syndrome. : A pilot intervention study.
Acronym
The effectiveness of dental health instructions for preventing lifestyle-related diseases.
Scientific Title
Evaluation of the effectiveness of dental health instructions for preventing lifestyle-related diseases of adults with metabolic syndrome or pre metabolic syndrome. : A pilot intervention study.
Scientific Title:Acronym
The effectiveness of dental health instructions for preventing lifestyle-related diseases.
Region
| Japan |
Condition
Condition
Lifestyle-related diseases: diabetes mellitus, obesity, hyperlipidemia, hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the effectiveness of dental health instructions for preventing lifestyle-related diseases of adults with metabolic syndrome or pre metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Weight, BMI, Abdominal girth, Systolic blood pressure, Diastolic blood pressure, HbA1c level, Fasting blood glucose level, LDL level, HDL level, Triglyceride level
Key secondary outcomes
Speed of eating, presence of snack habit, presence of smoking habit, presence of the will to improve dietary habit, presence of the will to improve smoking habit, Community Periodontal Index (CPI) scores, positive rate for hemoglobin in saliva, periodontal disease level measured by the questionnaire assessing self-reported periodontal health (20 questions).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Dental health instructions by dentist or dental hygienist along with the specific health guidance for 6 months.
Interventions/Control_2
Control group: Conduct only general health education, do not conduct dental health instructions.
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person diagnosed with metabolic syndrome or pre metabolic syndrome by specific health checkup
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Osaka |
Organization
Tohoku University Graduate School of Dentistry
Division name
Department of International and community oral health
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-7639
osaka@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Yamaki |
Organization
Mitsubishi Research Institute, Inc.
Division name
Human-Life Research Division
Zip code
100-8141
Address
10-3, Nagatacho 2-Chome Chiyoda-Ku, Tokyo 100-8141, Japan
TEL
03-6705-6024
Homepage URL
syamaki@mri.co.jp
Sponsor or person
Institute
Mitsubishi Research Institute, Inc.
Institute
Department
Personal name
Funding Source
Organization
Min. of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Public Health, Tokyo Medical and Dental University, National Center for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethical committee, Department of dentistry, Tohoku University
Address
4-1, Seiryo-machi,Aoba-ku,Sendai, Miyagi
Tel
022-717-8244
den-syom@grp.tohoku.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
佐久市立国保浅間総合病院（長野県）、公立みつぎ総合病院（広島県）、公立甲賀病院（滋賀県）、公立能登総合病院（石川県）、三豊総合病院（香川県）、まんのう町国保美合歯科診療所（香川県）、南砺市民病院（富山県）、諏訪中央病院（長野県）、国民健康保険平戸市民病院（長崎県）、国東市民病院（大分県）、損保ジャパン日本興亜（株）/ Asama General Hospital（Nagano）, Mitsugi General Hospital（Hiroshima）, KOUKA Public Hospital（Shiga）, Noto General Hospital（Ishikawa）, MITOYO General Hospital（Kagawa）, National Health Insurance Manno Souda Dental Clinic（Kagawa）, Nanto Municipal Hospital（Toyama）, Suwa Central Hospital（Nagano）, National Health Insurance Hirado Municipal Hospital（Nagasaki）, Kunisaki Municipal Hospital（Oita）,Sompo Japan Nipponkoa Insurance Inc.
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 31 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021408
