UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of effect of dental health service (dementia prevention)
Title of the study (Brief title)	Verification of effect of oral health management on cognitive function
Region	Japan

Condition
Condition	Mild cognitive decline
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of oral health management on cognitive function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improve cognitive function
Key secondary outcomes	Improve executive function Improvement of oral condition

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Oral hygiene instruction Oral gymnastics Training of tongue movement Pronunciation training Mastication training
Interventions/Control_2	Control
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	65 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Mild Cognitive Impairment
Key exclusion criteria	Participants have already been selected
Target sample size	60

Research contact person
Name of lead principal investigator	Hirano Hirohiko
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Dentistry and oral surgery
Address	35-2 Sakaecho Itabashi-ku Tokyo, Japan
TEL	03-3964-1141
Email	hhirano@tmig.or.jp

Public contact
Name of contact person	Watanabe Yutaka
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research on Social and Human Sciences
Address	35-2 Sakaecho Itabashi-ku Tokyo, Japan
TEL	03-3964-1141
Homepage URL
Email	ywata@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology Research on Social and Human Sciences
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare, japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mitsubishi Research Institute, Inc.
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
Anticipated trial start date	2018 Year 04 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 11 Day
Last modified on	2019 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036730