UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048936 |
|---|---|
| Receipt number | R000055754 |
| Scientific Title | Relationship between periodontitis and mild cognitive impairment: Pilot intervention study |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2022/09/15 14:05:11 |
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Basic information
Public title
Relationship between periodontitis and mild cognitive impairment
Acronym
Relationship between periodontitis and mild cognitive impairment
Scientific Title
Relationship between periodontitis and mild cognitive impairment: Pilot intervention study
Scientific Title:Acronym
Relationship between periodontitis and mild cognitive impairment
Region
| Japan |
Condition
Condition
Periodontitis and mild cognitive impairment
Classification by specialty
| Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the relationship between periodontitis and mild cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini-Mental State Examination (MMSE)
(Before the beginning of periodontitis treatment and 24 weeks after the beginning of periodontitis treatment)
Key secondary outcomes
Montreal Cognitive Assessment (MoCA)
Clock Drawing Test (CDT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Periodontitis treatment (mostly 3 times in 24 weeks)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed as mild cognitive impairment
(MMSE 24-27, and MoCA 25 or less)
Key exclusion criteria
1)Received anti-dementia drug treatment or periodontal disease treatment within the past 6 months
2)edentulous person
3)Hypertension, untreated at the time of consent
4)Hyperlipidemia, untreated at time of consent
5)diabetes mellitus, untreated at time of consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sadayuki |
| Middle name | |
| Last name | Hashioka |
Organization
Asahikawa Medical University
Division name
Department of Psychiatry
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
TEL
0166-68-2473
hashioka@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Yoshihara |
Organization
Asahikawa Medical University
Division name
Department of Psychiatry
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
TEL
0166-68-2473
Homepage URL
syoshi@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
Tel
0166-68-2297
rs-kk.g@asahikawa-med.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
| 2022 | Year | 09 | Month | 30 | 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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055754
