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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032205
Receipt No. R000036730
Scientific Title Verification of effect of dental health service (dementia prevention)
Date of disclosure of the study information 2018/04/11
Last modified on 2019/01/25

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Basic information
Public title Verification of effect of dental health service (dementia prevention)
Acronym Verification of effect of oral health management on cognitive function
Scientific Title Verification of effect of dental health service (dementia prevention)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirano Hirohiko
Organization Tokyo Metropolitan Institute of Gerontology
Division name Dentistry and oral surgery
Zip code
Address 35-2 Sakaecho Itabashi-ku Tokyo, Japan
TEL 03-3964-1141
Email hhirano@tmig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Watanabe Yutaka
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research on Social and Human Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 07 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036730

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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