UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048126 |
|---|---|
| Receipt number | 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 | 2023/09/06 09:10:39 |
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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
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
kmatsu30@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
The Lion Foundation for Dental Health
Institute
Department
Personal name
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
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
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054846
