UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058300 |
|---|---|
| Receipt number | R000066583 |
| Scientific Title | Factors associated with salivary bacterial counts in elderly people requiring nursing care |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/27 13:10:25 |
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Basic information
Public title
Factors associated with salivary bacterial counts in elderly people requiring nursing care
Acronym
Factors associated with salivary bacterial counts in elderly people requiring nursing care
Scientific Title
Factors associated with salivary bacterial counts in elderly people requiring nursing care
Scientific Title:Acronym
Factors associated with salivary bacterial counts in elderly people requiring nursing care
Region
| Japan |
Condition
Condition
older adults residing in nursing care homes
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether oral functions, including occlusal force and masticatory function, are associated with the number of bacteria in saliva among older people residing in nursing care homes.
Basic objectives2
Others
Basic objectives -Others
And to clarify the relationship between tongue pressure and other oral functions in order to explore strategies for maintaining tongue pressure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sex, age, grip strength, number of teeth, functional tooth unit (FTU), denture use, oral hygiene status, oral dryness, tongue coating index, tongue pressure, chewing ability, bite force, and number of bacteria in saliva were investigated.
Key secondary outcomes
Sex, age, grip strength, number of teeth, functional tooth unit (FTU), denture use, oral hygiene status, oral dryness, tongue coating index, tongue pressure, chewing ability, bite force, and number of bacteria in saliva were investigated.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older people residing in nursing care homes
Able to provide a saliva sample
Able to undergo tongue pressure measurement
Currently eating orally
Informed consent obtained from the individual or their legal representative
Key exclusion criteria
Able to walk independently
Individuals with neuromuscular diseases
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Funahara dental clinic
Division name
Dentistry
Zip code
675-0033
Address
22-1 Kakogawacho Minamibingo, Kakogawa-shi, Hyogo-ken, Japan
TEL
0794267620
macloca02@gmail.com
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Funahara dental clinic
Division name
Dentistry
Zip code
675-0033
Address
22-1 Kakogawacho Minamibingo, Kakogawa-shi, Hyogo-ken, Japan
TEL
0794267620
Homepage URL
macloca02@gmail.com
Sponsor or person
Institute
Funahara dental clinic, Dentistry, Madoka Funahara
Institute
Department
Personal name
Funding Source
Organization
Funding source: Self-funded
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
The Japanese Society of Oral Care
Address
22-5 Hoocho Chikusa-ku, Nagoya-shi, Aichi-ken 464-0057 Japan
Tel
052-784-5202
office@oralcare-jp.org
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
| 2025 | Year | 06 | Month | 27 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066583
