UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048651 |
|---|---|
| Receipt number | R000055438 |
| Scientific Title | Effects of oral care before sleep on oral bacteria in community-dwelling elderly people. |
| Date of disclosure of the study information | 2022/10/04 |
| Last modified on | 2022/09/02 20:03:57 |
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Basic information
Public title
Effects of oral care before sleep on oral bacteria in community-dwelling elderly people.
Acronym
Effects of oral care before sleep on oral bacteria in community-dwelling elderly people.
Scientific Title
Effects of oral care before sleep on oral bacteria in community-dwelling elderly people.
Scientific Title:Acronym
Effects of oral care before sleep on oral bacteria in community-dwelling elderly people.
Region
| Japan |
Condition
Condition
Community-dwelling healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As factors for the onset of aspiration pneumonia in the elderly, the number of oral bacteria in saliva, decreased swallowing function, cognitive function, and decreased activity have been reported. Aiming to develop an oral care method that contributes to the prevention of aspiration pneumonia, the aim is to perform oral care intervention before sleep for community-dwelling elderly people, to verify decreasing on the number of oral bacteria when waking up.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of oral bacteria after waking up 14 days after the start of oral care intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral care by brushing with toothpaste before sleep for 14 days - Washout period of 7 days - Oral care by brushing with toothpaste and rinsing with mouthwash before sleep for 14 days.
Interventions/Control_2
Oral care by brushing with toothpaste and rinsing with mouthwash before sleep for 14 days - Washout period of 7 days - Oral care by brushing with toothpaste before sleep for 14 days.
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
- 65 years and older
- Elderly people who can answer the questionnaire
- Elderly people who can rinse with mouthwash
- Elderly people who can use the toothbrush, toothpaste, and mouthwash used in the study
Key exclusion criteria
- Elderly people with a previous diagnosis of dysphagia
- Elderly people who use mouthwash on a daily basis
- Elderly people undergoing dental treatment
- Elderly people who have been treated with antibiotics within the past 2 weeks from the time of the survey
- Elderly people with edentulous
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikazura, Wakayama City Japan
TEL
073-446-6700
sakamoto-nc@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikazura, Wakayama City Japan
TEL
073-446-6700
Homepage URL
sakamoto-nc@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300(3692)
wa-rinri@wakayama-med.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 | 10 | Month | 04 | 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
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055438
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| Registered date | File name |
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| Registered date | File name |
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