UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	32
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	2017 Year 07 Month 31 Day
Date of IRB	2017 Year 07 Month 24 Day
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 12 Month 14 Day

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