UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037722