UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033885 |
|---|---|
| Receipt number | R000038647 |
| Scientific Title | Exploratory study on the change of oral hygiene condition by the food containing aroma component in elderly who requires nursing care |
| Date of disclosure of the study information | 2018/08/24 |
| Last modified on | 2019/04/11 09:39:07 |
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Basic information
Public title
Exploratory study on the change of oral hygiene condition by the food containing aroma component in elderly who requires nursing care
Acronym
Study on the change of oral hygiene condition by the food containing aroma component
Scientific Title
Exploratory study on the change of oral hygiene condition by the food containing aroma component in elderly who requires nursing care
Scientific Title:Acronym
Study on the change of oral hygiene condition by the food containing aroma component
Region
| Japan |
Condition
Condition
Elderly who requires nursing care
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of the food containing aroma component intake on oral hygiene condition in elderly who requires nursing care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total number of oral bacteria
Key secondary outcomes
1) Number of oral opportunistic pathogen
2) Oral condition
3) Activities of daily living
4) Disease morbidity (fever, pneumonia, etc.)
5) Periodontal bacteria
6) Periodontal pocket
7) Others (dietary intake, water intake, arterial oxygen saturation and body weight)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will receive oral administration of 5 g gel including aroma component twice daily (10 g/day).
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
| 117 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Oral hygiene condition:
total number of oral bacteria > mean of healthy adults
Key exclusion criteria
1) Severe disease
2) Swallowing is extremely difficult
3) Diagnosis of inappropriate by physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Obara |
Organization
Gifu Pharmaceutical University
Division name
Community Healthcare Pharmacy
Zip code
501-1196
Address
1-25-4 Daigakunishi, Gifu, JAPAN
TEL
058-230-8100
obara@gifu-pu.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Obara |
Organization
Gifu Pharmaceutical University
Division name
Community Healthcare Pharmacy
Zip code
501-1196
Address
1-25-4 Daigakunishi, Gifu, JAPAN
TEL
058-230-8100
Homepage URL
obara@gifu-pu.ac.jp
Sponsor or person
Institute
Community Healthcare Pharmacy, Gifu Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
UHA Mikakuto Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) School of Pharmaceutical Sciences, University of Shizuoka
2) Welgarden Ikoen
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Gifu Pharmaceutical University
Address
1-25-4 Daigakunishi, Gifu, JAPAN
Tel
058-230-8100
tanakam@gifu-pu.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
社会福祉法人ウエルガーデン・ウエルガーデン伊興園（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 24 | 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
50
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 08 | Month | 24 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
