UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046990 |
|---|---|
| Receipt number | R000053604 |
| Scientific Title | Cross-sectional study on the effect of mastication on tongue pressure and salivary bacteria in the older adults requiring long-term care |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2025/02/26 09:28:16 |
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Basic information
Public title
Cross-sectional study on the effect of mastication on tongue pressure and salivary bacteria in the older adults requiring long-term care
Acronym
Cross-sectional study on the effect of mastication on tongue pressure and salivary bacteria in the older adults requiring long-term care
Scientific Title
Cross-sectional study on the effect of mastication on tongue pressure and salivary bacteria in the older adults requiring long-term care
Scientific Title:Acronym
Cross-sectional study on the effect of mastication on tongue pressure and salivary bacteria in the older adults requiring long-term care
Region
| Japan |
Condition
Condition
The older adults requiring long-term care
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between mastication, tongue pressure, and the number of bacteria in saliva in the older adults requiring long-term care by cross-sectional study
Basic objectives2
Others
Basic objectives -Others
Reduced risk of aspiration pneumonia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum occlusal pressure
Chewing efficiency
Tongue pressure
Number of bacteria in saliva
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Older adults aged 65 and over who are in a facility or hospital and who require long-term care
2.Those who receive oral care
Key exclusion criteria
1.Those who cannot open/close the mouth or chewing according to the instructions of researchers
2.Patients with neuromuscular diseases such as muscular dystrophy, Parkinson's disease, and ALS
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
+81958197663
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197698
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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 Institutional Review Board (IRB) of Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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 | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prevention of aspiration pneumonia
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053604
