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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027724
Receipt No. R000031739
Scientific Title Effect of oral care tablet on reduction of bacteria in tongue coating and oral malodor
Date of disclosure of the study information 2017/07/31
Last modified on 2019/06/14

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Basic information
Public title Effect of oral care tablet on reduction of bacteria in tongue coating and oral malodor
Acronym Effect of oral care tablet
Scientific Title Effect of oral care tablet on reduction of bacteria in tongue coating and oral malodor
Scientific Title:Acronym Effect of oral care tablet
Region
Japan

Condition
Condition Oral malodor
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of the oral care tablet on reduction of bacteria in tongue coating and oral malodor of university students
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of oral malodor Volatile sulfur compounds
H2S
CH3SH
Evaluation of tongue coating accumulation
Measurement of oral bacteria
Total bacteria
Porphyromonas gingivalis
Fusobacterium nucleatum
Campylobacter rectus Assessment of oral microbiome
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Tongue cleaning
Interventions/Control_2 Intake of oral care tablet
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria University student who obtained with informed consent of this study
Key exclusion criteria Underlying disease
Smoker
Pregnant women
Intake of antibiotics within 2 weeks
Allergy against kiwi fruits and apple
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Hinode
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Hygiene and Oral Health Science
Zip code 770-8504
Address 18-15 Kuramotocho 3-chome, Tokushima, 770-8504 JAPAN
TEL 088-633-7543
Email hinode@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Hinode
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Hygiene and Oral Health Science
Zip code 770-8504
Address 18-15 Kuramotocho 3-chome, Tokushima, 770-8504 JAPAN
TEL 088-633-7543
Homepage URL
Email hinode@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokushima University Hospital
Address Kuramotocho 2-50-1, Tokushima city
Tel 088-633-9294
Email first-ec@tokushima-u.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
2017 Year 07 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 12 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031739

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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