UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025174 |
|---|---|
| Receipt number | 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 10:07:49 |
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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
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
ryoma73@nih.go.jp
Sponsor or person
Institute
National Institute of Infectious Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028961
| Research Plan | |
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| Registered date | File name |
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