UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy test of BOC777, composite for oral cavity
Title of the study (Brief title)	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 BOC777 for oral cavity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Collection of saliva, tongue plaque and dental plaque and measurement of oral index and questionnaire each of the 4 times, before starting test, after using BOC 777 for 2 weeks and 8 weeks and in 2 weeks after finishing using BOC 777.
Key secondary outcomes

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	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Rinsing with BOC777 in oral cavity for 30 seconds 3 times a day for 10 weeks.
Interventions/Control_2	Rinsing with positive control composite in oral cavity for 30 seconds 3 times a day for 10 weeks.
Interventions/Control_3	Rinsing with placebo composite in oral cavity for 30 seconds 3 times a day for 10 weeks.
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	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 -Subjects with bleeding from the gum
Key exclusion criteria	-Subjects with systemic illness -Subjects with a disease in the oral cavity and are consulting the medical institution -Subjects with the orthodontic therapy -Subjects with denture -The pregnant and subjects who hope to get pregnant during the exam period -Subjects who are taking prescription medicine -Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Hatsumi Souno
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7461
Homepage URL
Email	souno.hatsumi@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	花王株式会社研究所（栃木県、東京都、和歌山県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 24 Day
Anticipated trial start date	2016 Year 10 Month 04 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	2016 Year 09 Month 15 Day
Last modified on	2017 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027713