UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of oral health promotion on Lifestyle-related diseases
Title of the study (Brief title)	The effects of oral health promotion on Lifestyle-related diseases
Region	Japan

Condition
Condition	lifestyle-related disease
Classification by specialty	Medicine in general Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is conducted the effects of oral health promotion on lifestuyle-related diseases such as diabetes condition and aceton of mouth air.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c check baseline and 1,3,6M after oral health care promotion
Key secondary outcomes	oral malodor(VSC,Aceton), periodontal tissue condition, blood glucose level, etc. check baseline and 1,3,6M after oral health care promotion

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	oral health care promotion are carried out at first, 1, 3M visits and check at first, 1, 3, 6M visits.
Interventions/Control_2
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with lifestyle-related diseases such as diabetes
Key exclusion criteria	patients with infection diseases and serious condition
Target sample size	100

Research contact person
Name of lead principal investigator	Shinada Kayoko
Organization	Tokyo Medical and Dental University, graduate school
Division name	preventive oral health care science
Address	1-5-45Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-4096
Email	shinada.ohp@tmd.ac.jp

Public contact
Name of contact person	Shinada Kayoko
Organization	Tokyo Medical and Dental University, graduate school
Division name	preventive oral health care science
Address	1-5-45Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-4096
Homepage URL
Email	shinada.ohp@tmd.ac.jp

Sponsor
Institute	Preventive oral health care science, Tokyo Medical and Dental University, graduate school
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	東京医科歯科大学医学部付属病院（東京都）、東京医科歯科大学歯学部口腔保健学科研究室および実習室（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 02 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 09 Month 02 Day
Anticipated trial start date	2015 Year 09 Month 08 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 02 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021860