UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022886 |
|---|---|
| Receipt number | R000026376 |
| Scientific Title | The effect of functiona water rinsing for aged persons |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2021/06/30 16:06:43 |
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Basic information
Public title
The effect of functiona water rinsing for aged persons
Acronym
Rinsing with functional water
Scientific Title
The effect of functiona water rinsing for aged persons
Scientific Title:Acronym
Rinsing with functional water
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of gargling with functionak water in oaral environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the nunmer of oral bacteria in saiva, on surfaces of mucosa and aratificialtooth at 0, 2, and 4 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Ozone nanobubble water
Interventions/Control_2
WEAK ACIDIC ELECTROLYTIC WATER
Interventions/Control_3
Concool F
Interventions/Control_4
RO water
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
aged peroson
Key exclusion criteria
The subjects who have taken antibiotics within 3 months.
The subjects who cuold not be obtained informed consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | SHINICHI |
| Middle name | |
| Last name | ARAKAWA |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Lifetime Oral Health Care Science
Zip code
1138549
Address
1-5-45 Yushima Bunkyo-Ku, Tokyo
TEL
03-5803-4649
solan.ltoh@tmd.ac.jp
Public contact
Name of contact person
| 1st name | SHINICHI |
| Middle name | |
| Last name | ARAKAWA |
Organization
TTokyo Medical and Dental University Graduate School
Division name
Lifetime Oral Health Care Science
Zip code
1138549
Address
1-5-45 Yushima Bunkyo-Ku, Tokyo
TEL
03-5803-4649
Homepage URL
solan.ltoh@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-Ku Tokyo, JAPAN
Tel
0358034968
shinperi@tmd.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
| 2016 | Year | 08 | Month | 31 | 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
| 2016 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2016 | Year | 06 | Month | 25 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026376
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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