UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032636 |
|---|---|
| Receipt number | R000037207 |
| Scientific Title | Comparative Study on Removal Method of Oral Bacteria in Oral Care |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/07/10 13:42:22 |
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Basic information
Public title
Comparative Study on Removal Method of Oral Bacteria in Oral Care
Acronym
Comparative Study on Removal Method of Oral Bacteria in Oral Care
Scientific Title
Comparative Study on Removal Method of Oral Bacteria in Oral Care
Scientific Title:Acronym
Comparative Study on Removal Method of Oral Bacteria in Oral Care
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative Study on Removal Method of Oral Bacteria in Oral Care
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of oral bacteria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
suction
Interventions/Control_2
wipe
Interventions/Control_3
with water
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteer with >20 tooth
Key exclusion criteria
orthdontic appliance
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Sumi |
Organization
Japanese National Center for Geriatrics and Gerontology
Division name
Department for Advanced Dental Research, Center for Development of Advanced Medicine for Dental and Oral Diseases,
Zip code
474-8511
Address
7-430 Morioka-cho, Obu-city, Aichi 474-8511, Japan
TEL
0562-46-2311
yasusumi@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Moriya |
Organization
Japanese National Center for Geriatrics and Gerontology
Division name
Division of Oral and Dental Surgery, Department of Advanced Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu-city, Aichi 474-8511, Japan
TEL
0562-46-2311
Homepage URL
meg022@ncgg.go.jp
Sponsor or person
Institute
Japanese National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japanese National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu-city, Aichi 474-8511, Japan
Tel
0562462311
sumiyami@ncgg.go.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
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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 | 03 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037207
| 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 |
