UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033380 |
|---|---|
| Receipt number | R000038059 |
| Scientific Title | Study of the relationship between oral function and cognitive decline in elderly people |
| Date of disclosure of the study information | 2018/07/13 |
| Last modified on | 2021/07/14 16:38:52 |
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Basic information
Public title
Study of the relationship between oral function and cognitive decline in elderly people
Acronym
Study of the relationship between oral function and cognitive decline
Scientific Title
Study of the relationship between oral function and cognitive decline in elderly people
Scientific Title:Acronym
Study of the relationship between oral function and cognitive decline
Region
| Japan |
Condition
Condition
Elderly person including mild cognitive impairment (MCI) individual
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of the change of oral function on the cognitive decline in elderly people including mild cognitive impairment(MCI) individual
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of MCI biomarkers during 2 year
Key secondary outcomes
oral function, oral state
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) the patients who participated in research theme "Examination of relationship between oral function and cognitive decline in mild cognitive impairment elderly people with mild cognitive impairment"(Fukuoka Gakuen permission number No. 329)
(2) written informed consent provided for study participation
(3)the outpatient of Geriatric Dentistry in Fukuoka Dental College Hospital
(4) 65 years-old <=
(5) normal cognitive function and MCI
Key exclusion criteria
(1) patient with dementia
(2) others whom the principal investigator decides to exclude
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mizutani |
Organization
Kyushu University
Division name
Section of Geriatric Dentistry and Perioperative Medicine in Dentistry, Division of Maxillofacial Diagnostic and Surgical Sciences Faculty of Dental Science
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
TEL
092-642-6485
mizutani@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Shinsuke |
Organization
Kyushu University
Division name
Section of Geriatric Dentistry and Perioperative Medicine in Dentistry, Division of Maxillofacial Di
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
TEL
092-642-6485
Homepage URL
mizutani@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka dental college
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
Tel
092-642-5774
ijkseimei@jimu.kyushu-u.ac.jp
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 | 07 | Month | 13 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/joor.13224
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/joor.13224
Number of participants that the trial has enrolled
54
Results
The follow-up rate in this study was 67%. The masticatory performance was improved (P<0.001), whereas gingival inflammation was decreased (P < 0.001) over the 2-year period. A significant increase in the MMSE score (P <0.001) and a decrease in MCI risk (P<0.001) were noted. The decrease in MCI risk was correlated with the increase in both masticatory performance (P<0.05) and MMSE score (P<0.01).
Results date posted
| 2021 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 07 | Month | 09 | Day |
Baseline Characteristics
See the journal publication of results
Participant flow
See the journal publication of results
Adverse events
No
Outcome measures
MCI risk
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 07 | Month | 14 | Day |
Other
Other related information
observational study
study design: cohort study
Management information
Registered date
| 2018 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038059
