UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031392 |
|---|---|
| Receipt number | 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 17:11:25 |
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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
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
kyoumu@taiyodhs.ac.jp
Sponsor or person
Institute
Taiyo school of dental hygiene
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035837
