UMIN-CTR Clinical Trial

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
Email	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
Email	syoshi@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055754