UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy test of the product combined a new detergent.
Title of the study (Brief title)	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	Yano Yoshitaka
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
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	Teppei Tajikara
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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