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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034945
Receipt No. R000039799
Scientific Title Effect of the Test Product for Caries-Causing Bacteria and Periodontal Disease Bacteria.
Date of disclosure of the study information 2018/11/20
Last modified on 2018/12/04

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Basic information
Public title Effect of the Test Product for Caries-Causing Bacteria and Periodontal Disease Bacteria.
Acronym Effect of the Test Product for Caries-Causing Bacteria and Periodontal Disease Bacteria.
Scientific Title Effect of the Test Product for Caries-Causing Bacteria and Periodontal Disease Bacteria.
Scientific Title:Acronym Effect of the Test Product for Caries-Causing Bacteria and Periodontal Disease Bacteria.
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate effect of the test product for caries-causing bacteria and periodontal disease bacteria.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Oral examination for caries-causing bacteria and periodontal disease bacteria (not applying the test product [1 time; 0 min, 30 min and 180 min after applying]; applying the test product [1 time; 0 min, 30 min and 180 min after applying]).
Key secondary outcomes *Safety
[1]Dentist's questions (not applying the test product [1 time; 0 min, 30 min and 180 min after applying]; applying the test product [1 time; 0 min, 30 min and 180 min after applying]).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 [1]Applying test product (1 time).
[2]Not applying test product (1 time).
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria [1]Japanese males and females aged 20 and over years.
[2]Individuals who have mild periodontal disease (ex. redness of the gums, bleeding from the gums, bad breath).
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can come to the designated venue for this study and be inspected.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals who are under dental treatment.
[3]Individuals using artificial teeth and dental implant (except upper right and left #6, #7, and #8 and lower right and left #6, #7, and #8).
[4]Individuals who have temporomandibular joint disorder.
[5]Individuals who are sensitive to metal, foods, and latex.
[6]Individuals who have photosensitivity.
[7]Individuals who have a habit to use mouthwash.
[8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[9]Individuals with serious anemia.
[10]Individuals who are, are possibly or are lactating, or plan to get pregnant during the test period.
[11]Individuals who are depending on alcohol or have other mental diseases.
[12]Individuals who are smoker.
[13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[14]Individuals who participated in other clinical studies in the past 3 months.
[15]Individuals judged inappropriate for the study by the principal.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code
Address Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL 03-6240-1162
Email t.ono@ueno-asagao.clinic

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code
Address Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization Aquafree Investment Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 20 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 Completed
Date of protocol fixation
2018 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 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 11 Month 20 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039799

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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