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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026455
Receipt No. R000030391
Scientific Title Efficacy test of the product combined a new detergent.
Date of disclosure of the study information 2017/03/08
Last modified on 2017/08/22

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Basic information
Public title Efficacy test of the product combined a new detergent.
Acronym Efficacy test of a new detergent.
Scientific Title Efficacy test of the product combined a new detergent.
Scientific Title:Acronym Efficacy test of a new detergent.
Region
Japan

Condition
Condition Gingivitis, Periodontitis, Oral malodor
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of a new detergent for oral condition and microbial flora.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral condition and bacterial flora before and after using the product.
Key secondary outcomes Oral bacterial flora
Probing pocket depth (PPD)
Gingival index (GI)
Bleeding on probing (BOP)
Dental plaque

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 Prevention
Type of intervention
Other
Interventions/Control_1 Using a new detergent product for 3 months
Interventions/Control_2 Using a Placebo for 3 months
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

Not applicable
Gender Male
Key inclusion criteria Over 40 years old males
Key exclusion criteria 1. Subjects who received treatment of oral disease in dental clinic
2. Subjects with serious wound in the oral cavity
3. Subjects with severe inflammation of the gingiva
4. Subjects with full denture
5. Subjects who have no intension use supplied products.
6. Subjects who was judged inappropriate by researcher
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yano Yoshitaka
Organization Kao Corporation
Division name R&D-Development Research-Personal Health Care Products Research
Zip code
Address 2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL 03-5630-9751
Email yanou.yoshitaka@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Tajikara
Organization Kao Corporation
Division name R&D-Development Research-Personal Health Care Products Research
Zip code
Address 2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL 03-5630-9750
Homepage URL
Email tajikara.teppei@kao.co.jp

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
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
2017 Year 03 Month 08 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
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 08 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
2017 Year 03 Month 08 Day
Last modified on
2017 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030391

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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