UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000021408