UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040873 |
|---|---|
| Receipt number | R000046672 |
| Scientific Title | Survey on oral function management methods according to the degree of cognitive decline |
| Date of disclosure of the study information | 2020/06/24 |
| Last modified on | 2020/06/23 19:15:26 |
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Basic information
Public title
Survey on oral function management methods according to the degree of cognitive decline
Acronym
Survey on oral function management methods according to the degree of cognitive decline
Scientific Title
Survey on oral function management methods according to the degree of cognitive decline
Scientific Title:Acronym
Survey on oral function management methods according to the degree of cognitive decline
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the aging of the population, the rapid increase of dementia patients has become a social issue in Japan. The condition of dementia changes depending on its type and stage (stage). To investigate the method of dental treatment for patients with dementia at each stage, and clarify the appropriate oral management method at each stage.
Basic objectives2
Others
Basic objectives -Others
To investigate the method of swallowing rehabilitation for patients with dementia at each stage, and clarify the appropriate oral management method at each stage.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE, HDS-R
DMFT, PCR,
FOIS
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly patients with dementia who received visiting medical treatment
Key exclusion criteria
Not covered by treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Iida |
Organization
Kanagawa Dental University
Division name
Division of Medically Compromised Geriatric Dentistry
Zip code
238-8570
Address
yokosuka city ogawa chou 1-23
TEL
0468228874
takatoshii0330@gmail.com
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Iida |
Organization
Kanagawa Dental University
Division name
Division of Medically Compromised Geriatric Dentistry
Zip code
238-8570
Address
yokosuka city ogawa chou 1-23
TEL
0468228874
Homepage URL
takatoshii0330@gmail.com
Sponsor or person
Institute
Kanagawa Dental University
Division of Medically Compromised Geriatric Dentistry
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Division of Medically Compromised Geriatric Dentistry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
yokosuka city ogawa chou 1-23
Tel
0468228874
takatoshii0330@gmail.com
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
| 2020 | Year | 06 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is a preliminary test
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046672
