UMIN-CTR Clinical Trial

Public title

Evaluation test for oral cavity

Acronym

Evaluation test for oral cavity

Scientific Title

Evaluation test of composition 210515 for oral cavity

Scientific Title:Acronym

Evaluation test for oral cavity

Region

Japan

Condition

Healthy adults

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the efficacy of composition 210515 for oral cavity

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Measurement of oral index. Measurements are taken 3 times, before starting test, after using composion 210515 for 12 weeks and 24 weeks.

Key secondary outcomes

Taking photography of oral cavity and questionnaire. Each measurement are taken 3 times, before starting test, after using composite210515 for 12 weeks and 24 weeks.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Brushing teeth with oral composition 210515 for 24 weeks.

Interventions/Control_2

Brushing teeth with placebo composition for 24 weeks.

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

40

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Male and Female

Key inclusion criteria

-Male or female of 40 to 69 years of age
-Subjects who can come to the test site by their own
-Subjects who can sign by their own will
-1or2, and 3or4or5
1.Subjects who feel that their gums are falling and their teeth are getting longer.
2.Subjects who feel that food gets stuck between their teeth.
3.Subjects who may bleed from gingival.
4.gingival.
5.Subjects have been diagnosed with swollen gingival or deep periodontal pockets.
-Subjects who have 20 or more of their own teeth.

Key exclusion criteria

-Subjects with systemic illness.
-Subjects with a disease in the oral cavity and are consulting the medical institution.
-Subjects with periodontal disease is treated.
-Subjects with the orthodontic therapy.
-Subjects with mobile tooth.
-Subjects with an implant.
-Subjects who have regular dental checkups at least three times a year.
-Subjects who have been prescribed antibiotics for swollen gingival within a year.
-The pregnant and subjects who hope to get pregnant during the exam period.
-Subjects who are taking prescription medicine (except for anti-hay fever).
-Subjects from outside the company who work in an advertising agency, an investigation, consultancy, mass communication, and the manufacturing industry of health food, cosmetics, toiletries, a sanitary items, and a distributive trade.
-Subjects who participate in the other examinations.
-Subjects who had health problems (fever, cold-like symptom, abnormal taste or smell, etc.) within 2 weeks prior to the test,
or subjects who had a family member living with them who showed abnormalities.
-Subjects who had close contact with COVID-19 infected individuals within 2 weeks prior to the study.
-Subjects who are confirmed positive in the COVID-19 antigen test on the day of measurement.
-Subjects deemed inappropriate to participate in this study by the principle investigator.

Target sample size

50

Name of lead principal investigator

1st name	hidefumi
Middle name
Last name	kitazawa

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

TEL

+81-70-3296-8218

Email

kitazawa.hidefumi@kao.com

Name of contact person

1st name	Hatsumi
Middle name
Last name	Souno

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

TEL

+81-70-4356-2759

Homepage URL

Email

souno.hatsumi@kao.com

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Human Reserach Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社（東京都）

Date of disclosure of the study information

2021

Year

06

Month

11

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

Preinitiation

Date of protocol fixation

2021

Year

05

Month

15

Day

Date of IRB

2021

Year

06

Month

08

Day

Anticipated trial start date

2021

Year

06

Month

11

Day

Last follow-up date

2022

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2023

Year

03

Month

31

Day

Other related information

Registered date

2021

Year

06

Month

09

Day

Last modified on

2021

Year

06

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050819