UMIN-CTR Clinical Trial

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

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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]).

Study type

Interventional

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

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

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

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

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

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Aquafree Investment Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

11

Month

20

Day

Last modified on

2018

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039799