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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031392
Receipt No. R000035837
Scientific Title Preliminary study, by chewing gum, to evaluate the changes on saliva component, oral hygiene and masticatory function.
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/20

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Basic information
Public title Preliminary study, by chewing gum, to evaluate the changes on saliva component, oral hygiene and masticatory function.
Acronym Evaluation of the saliva metabolomics, and the changes in oral hygiene and masticatory function.
Scientific Title Preliminary study, by chewing gum, to evaluate the changes on saliva component, oral hygiene and masticatory function.
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Matsukubo
Organization Taiyo school of dental hygiene
Division name President
Zip code
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
1st name
Middle name
Last name Akane Takenouchi
Organization Taiyo school of dental hygiene
Division name Daytime class
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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