UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033204 |
|---|---|
| Receipt number | R000037722 |
| Scientific Title | Evaluation of the effectiveness of tongue cleaning: focus on the influence on oral and intestinal microbiota by tongue cleaning |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2020/01/06 10:45:54 |
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Basic information
Public title
Evaluation of the effectiveness of tongue cleaning: focus on the influence on oral and intestinal microbiota by tongue cleaning
Acronym
Evaluation of the effectiveness of tongue cleaning
Scientific Title
Evaluation of the effectiveness of tongue cleaning: focus on the influence on oral and intestinal microbiota by tongue cleaning
Scientific Title:Acronym
Evaluation of the effectiveness of tongue cleaning
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between oral and intestinal microbiota and the effectiveness of tongue cleaning from the preventive medicine perspective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Composition of oral and intestinal microbiota
Key secondary outcomes
Oral health-related QOL
Ayurvedic digestive power level
Tongue coating level
Dental plaque level
Blood pressure
Body weight
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Immediate intervention group: self tongue cleaning, once a day after getting up, for 12 weeks.
Wait-list group: waiting for 12 weeks.
Interventions/Control_2
Wait-list group: after waiting for 12 weeks, self tongue cleaning, once a day after getting up, for 12 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals complaining of lassitude, fatigue, sleepiness during daytime, loss of appetite in the past one month.
Key exclusion criteria
1. Any underlying disease
2. Pregnant women/possibility of pregnancy
3. Undergoing oral treatment or planning to undergo oral treatment during study period
4. Diagnosed at first visit as oral treatment required
5. Taking medicines or supplements which may have effects on digestive system
6. Took antibiotic therapy in the previous 1 month
7. Already practicing tongue scraping
8. Any abnormality in the tongue such as pain and inflamation
9. Metal allergy
10. Any other inadequacy as a subject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morita |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Preventive Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
mmorita@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Tokinobu |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Primary Care and Medical Education
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6963
Homepage URL
tokichin@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岡山大学病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | 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 | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037722
| 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 |
