UMIN-CTR Clinical Trial

Basic information
Public title	Clinical survey to clarify the association between periodontal disease, oral and cognitive functions
Acronym	Periodontal disease assessment study (Pearl study)
Scientific Title	Clinical survey to clarify the association between periodontal disease, oral and cognitive functions: an observational study
Scientific Title:Acronym	Periodontal disease assessment study (Pearl study)
Region	Japan

Condition
Condition	mild cognitive impairment, dementia, and periodontal disease
Classification by specialty	Medicine in general Neurology Geriatrics Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify associations between periodontal disease, oral, and cognitive functions
Basic objectives2	Others
Basic objectives -Others	oral function, dental status, cognitive function, activities of daily living
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	periodontal disease, oral, and cognitive functions
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
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Interventions/Control_4
Interventions/Control_5
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We enrolled patients visiting the memory clinic at the NCGG who agreed to undergo both medical assessment of their cognitive function and dental examination to survey periodontal disease. Patients were eligible for the study if they: (1) were able to undergo brain MRI; (2) provided informed consent in writing; (3) provided informed consent for the NCGG Biobank to store their clinical data, and blood samples; and (4) were accompanied by a study partner who could assess the condition of the patient.
Key exclusion criteria	We excluded patients if they: (1) were unable to undergo MRI examination, or the MRI scan could not be evaluated because of movement; (2) had local lesions, such as cerebral infarction, detected by MRI before enrollment, which could significantly affect cognitive functioning; (3) had a history of a major psychological disorder, or current serious or unstable alcohol or drug abuse; (4) were judged by an investigator to be ineligible to participate as a study subject.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Matsushita
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Oral Disease Research, Research Institute
Zip code	474-8511
Address	7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL	0562-44-5651
Email	kmatsu30@ncgg.go.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Matsushita
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Oral Disease Research, Research Institute
Zip code	474-8511
Address	7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL	0562-44-5651
Homepage URL
Email	kmatsu30@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology The Lion Foundation for Dental Health
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology The Lion Foundation for Dental Health
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	The Lion Foundation for Dental Health
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430, Morioka, Obu, Aichi 474-8511 Japan
Tel	0562-46-2311
Email	yaday@ncgg.go.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	国立長寿医療研究センター、公益財団法人ライオン歯科衛生研究所

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 21 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	Suspended
Date of protocol fixation	2021 Year 05 Month 12 Day
Date of IRB	2021 Year 07 Month 16 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	on-going.

Management information
Registered date	2022 Year 06 Month 21 Day
Last modified on	2022 Year 06 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054846

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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