UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015262 |
|---|---|
| Receipt number | R000017741 |
| Scientific Title | Investigation related to dental factor and cognitive function |
| Date of disclosure of the study information | 2014/09/29 |
| Last modified on | 2017/01/06 11:13:01 |
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Basic information
Public title
Investigation related to dental factor and cognitive function
Acronym
Investigation related to dental factor and cognitive function
Scientific Title
Investigation related to dental factor and cognitive function
Scientific Title:Acronym
Investigation related to dental factor and cognitive function
Region
| Japan |
Condition
Condition
All the diseases in the dental medicine field
Classification by specialty
| Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of cognitive function in patients visiting dentists and investigation of dental medicine-associated factors
Basic objectives2
Others
Basic objectives -Others
Frequency stratified by cognitive function and influencing factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Examination of cognitive function:Japanese version of Montreal Cognitive Assessment (MoCA-J)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)A Japanese patient aged >=65 years at the time his/her consent is acquired
(2)A patient who gives his/her written consent after an explanation of the investigation
Key exclusion criteria
(1)A patient who has dementia or has been previously diagnosed with dementia
(2) A patient who has or previously had cerebral stroke, schizophrenia or depression
(3)A patient being treated with an antidementia, antidepressant, psychotropic or antianxiety drug
(4)A patient other than the above whom a physician in charge of the investigation judges as ineligible for participation in the investigation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yanase |
Organization
Medical corporation Taihokai
Division name
Yanase Dental Clinic
Zip code
Address
East Aray Bldg 4F. 1-3-9 Higashibenzai, Asaka-shi, Saitama, 351-0022, Japan
TEL
048-476-0156
t-yanase@yanase-dental.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Yokota |
Organization
QOL RD Co.,Ltd.
Division name
Business Planning Division
Zip code
Address
Front Place Nihonbashi Bldg.2-14-1,
TEL
03-6386-8807
Homepage URL
a-yokota@qol-rd.co.jp
Sponsor or person
Institute
A public interest incorporated association The Japan Institute for Advanced Dentistry
Institute
Department
Personal name
Funding Source
Organization
A public interest incorporated association The Japan Institute for Advanced Dentistry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2014 | Year | 09 | Month | 29 | 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
| 2014 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2014 | Year | 09 | Month | 26 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017741
