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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018500
Receipt No. 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

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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
Email 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
Email syamaki@mri.co.jp

Sponsor
Institute Mitsubishi Research Institute, Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021408

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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