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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033204
Receipt No. 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 2018/08/30

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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
Email 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
Email tokichin@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037722

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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