UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the actual condition survey for oral cavity(721)
Title of the study (Brief title)	Correlational analysis of oral cavity substance(721)
Region	Japan

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

Objectives
Narrative objectives1	To analyze the relevance between oral cavity substance and oral cavity state
Basic objectives2	Others
Basic objectives -Others	To analyze the relevance between oral cavity substance and oral cavity state
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Collection of saliva, dental plaque and oral cavity mucosa, and measurement of oral index and questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Collection of saliva, dental plaque and oral cavity mucosa, and measurement of oral index and questionnaire.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	-Male or female of ranging in age from 20 to 69 years -Subjects who can come to the examination hall by themselves
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 -Subjects who took the antibiotic within two weeks -Subjects who participate in the other examinations which have an influence on this examination -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 deemed inappropriate to participate in this study by the principle investigator
Target sample size	150

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	Self funding
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	花王株式会社栃木研究所（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 03 Month 11 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	150 subjects(male and female) aged 20-69 will be recruited. Collection of saliva, dental plaque and oral cavity mucosa, and measurement of oral index and questionnaire. Measurement, only once for one person.

Management information
Registered date	2016 Year 03 Month 10 Day
Last modified on	2016 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024705