UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study, by chewing gum, to evaluate the changes on saliva component, oral hygiene and masticatory function.
Title of the study (Brief title)	Evaluation of the saliva metabolomics, and the changes in oral hygiene and masticatory function.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purposes of this study were, by chewing gum, to evaluate exhaustively the changes in salivary components with metabolomics, and also to evaluate oral hygiene (including salivary secretion rate, salivary cariogenic bacterial level, plaque formation, and gingivitis), and mental health and masticatory abilities.
Basic objectives2	Others
Basic objectives -Others	usefulness of chewing
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Saliva metabolome analysis after one-day and four-weeks chewing gum of tasteless and odorless (7 times / day, 10 minutes / time).
Key secondary outcomes	Evaluation of oral condition (salivary secretion rate, salivary cariogenic bacterial level, plaque formation, gingivitis, etc.), mental health, and masticatory abilities.

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	Food
Interventions/Control_1	Saliva are collected four weeks before chewing tasteless and odorless gum [about 10 minutes, 7 times per day], just before, one day after, and four weeks after, and carried out metabolome analysis. In addition, four weeks before chewing the gum, just before, and four weeks after, oral condition (salivary secretion rate, salivary cariogenic bacterial level, plaque formation, gingivitis, etc.), mental health, and masticatory abilities are evaluated.
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	21 years-old >=
Gender	Male and Female
Key inclusion criteria	17 students (20-21 years old), who got their consent, in Taiyo school of dental hygiene were chosen as volunteers. Through public offering by posting, we reminded them that participate in research is voluntary and is not mandatory. They receive informed consent for research, and participate in this research with agreement.
Key exclusion criteria	The following persons are excluded from subjects: Persons who have some medical history in mind and body, who have with gingivitis and periodontitis, who need basic periodontal therapy, teeth requiring treatment, those having a tooth under treatment, those taking ordinary medicines, daily life Those that frequently chew gum.
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Matsukubo
Organization	Taiyo school of dental hygiene
Division name	President
Address	Station plaza tower 6F 2-22-1, nishi-nippori, arakawa-ku, Tokyo
TEL	03-5810-8020
Email	matukubo@tdc.ac.jp

Public contact
Name of contact person	Akane Takenouchi
Organization	Taiyo school of dental hygiene
Division name	Daytime class
Address	Station plaza tower 6F 2-22-1, nishi-nippori, arakawa-ku, Tokyo
TEL	03-5810-8020
Homepage URL
Email	kyoumu@taiyodhs.ac.jp

Sponsor
Institute	Taiyo school of dental hygiene
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
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	医療法人社団友和会 太陽歯科衛生士専門学校（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 07 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 27 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	2018 Year 02 Month 20 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035837