UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027724
Receipt number 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 2019/12/14 09:36:16

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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 or person

Institute

Tokushima University Graduate School of Biomedical Sciences

Institute

Department

Personal name



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

Value
https://center6.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