UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032205 |
|---|---|
| Receipt number | 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 14:11:25 |
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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
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
ywata@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology Research on Social and Human Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036730
