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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033885
Receipt No. 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

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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
Email 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
Email obara@gifu-pu.ac.jp

Sponsor
Institute Community Healthcare Pharmacy, Gifu Pharmaceutical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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