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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044482
Receipt No. R000050819
Scientific Title Evaluation test of composition 210515 for oral cavity
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/09

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Basic information
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
Condition Healthy adults
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 11 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 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
Other related information

Management information
Registered date
2021 Year 06 Month 09 Day
Last modified on
2021 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050819

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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