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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000048126
Receipt No. R000054846
Scientific Title Clinical survey to clarify the association between periodontal disease, oral and cognitive functions: an observational study
Date of disclosure of the study information 2022/06/21
Last modified on 2022/06/21

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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
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

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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