UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy test of 19220, composite for oral cavity
Acronym	Efficacy test for oral cavity
Scientific Title	The efficacy test of 19220, composite for oral cavity
Scientific Title:Acronym	Efficacy 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 confirm the efficacy of composite 19220 for oral cavity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the dental plaque quantity, collection of dental plaque and saliva, photograph of oral cavity, and questionnaire after consecutive 3 days use of 19220 following tooth cleaning
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	10
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_2	Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_3	Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_4	Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_5	Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_6	Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_7	Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_8	Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_9	Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days.
Interventions/Control_10	Rinsing with placebo composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-1 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with 19220 composite in oral cavity for 30 seconds 9 times per 3 days. After washout over 4 days, Rinsing with positive control-2 composite in oral cavity for 30 seconds 9 times per 3 days.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Male or female of 20 to 59 years of age
Key exclusion criteria	-Subjects with systemic illness -Subjects with a disease in the oral cavity and are consulting the medical institution -Subjects undergoing orthodontic therapy -Subjects with denture -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 deemed inappropriate to participate in this study by the principle investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yoshihiko Middle name Last name Minegishi
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7820
Email	minegishi.yoshihiko@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	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7450
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 Research Ethics Committee, Kao Corporation
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-9220
Email	uesaka.toshio@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（栃木県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 25 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	2019 Year 03 Month 15 Day
Date of IRB	2019 Year 03 Month 15 Day
Anticipated trial start date	2019 Year 03 Month 25 Day
Last follow-up date	2020 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 25 Day
Last modified on	2019 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041340