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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025174
Receipt No. R000028961
Scientific Title Investigation regarding preventive effect of topical application of propolis gel onto oral mucosa on periodontal disease and aspiration pneumonia in elderly
Date of disclosure of the study information 2016/12/07
Last modified on 2017/06/07

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Basic information
Public title Investigation regarding preventive effect of topical application of propolis gel onto oral mucosa on periodontal disease and aspiration pneumonia in elderly
Acronym Investigation about preventive effect of propolis on periodontal disease and aspiration pneumonia in elderly
Scientific Title Investigation regarding preventive effect of topical application of propolis gel onto oral mucosa on periodontal disease and aspiration pneumonia in elderly
Scientific Title:Acronym Investigation about preventive effect of propolis on periodontal disease and aspiration pneumonia in elderly
Region
Japan

Condition
Condition Periodontal disease and aspiration pneumonia
Classification by specialty
Pneumology Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate preventive effect of propolis on periodontal disease and pneumonia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of bacteria and microflora in oral cavity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 propolis gel
1%
every day for 1 month
Interventions/Control_2 placebo gel
every day for 1 month
Interventions/Control_3 Chlorhexidine gluconate gel
0.05%
every day for 1 month
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 More than one tooth remains.
There is no history to have antibiotics for more than 3 months.
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoma Nakao
Organization National Institute of Infectious Diseases
Division name Department of Bacteriology I
Zip code
Address 1-23-1, Toyama, Shinjuku-ku, Tokyo
TEL 03-5285-1111
Email ryoma73@nih.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Nakao
Organization National Institute of Infectious Diseases
Division name Department of Bacteriology I
Zip code
Address 1-23-1, Toyama, Shinjuku-ku, Tokyo
TEL 03-5285-1111
Homepage URL
Email ryoma73@nih.go.jp

Sponsor
Institute National Institute of Infectious Diseases
Institute
Department

Funding Source
Organization Yamada research grant
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 720
Org. issuing International ID_1 National Institute of Infectious Diseases
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions グループホーム のぞみの家i(あい)(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 07 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
2016 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 17 Day
Last follow-up date
2017 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 07 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028961

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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