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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007962
Receipt No. R000009371
Scientific Title Consideration of effects of commercial xylitol chewing gum on improvement in oral environment
Date of disclosure of the study information 2012/05/15
Last modified on 2012/05/15

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Basic information
Public title Consideration of effects of commercial xylitol chewing gum on improvement in oral environment
Acronym Effect of xylitol chewing gum on improvement in oral environment
Scientific Title Consideration of effects of commercial xylitol chewing gum on improvement in oral environment
Scientific Title:Acronym Effect of xylitol chewing gum on improvement in oral environment
Region
Japan

Condition
Condition Oral discomfort
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Xylitol chewing gum is used in subjects under conditions difficult to do mouth cleaning to evaluate effects on improvement in oral environment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral discomfort
Key secondary outcomes Composition of oral bacteria

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Use of two tablets xylitol chewing gum maximum 7 times /day for 4 days.
Interventions/Control_2 Don't use xylitol chewing gum.
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
60 years-old >=
Gender Male
Key inclusion criteria Member of Japan Ground Self-Defence Force attending field exercise
Key exclusion criteria 1) Infant
2) Edentulous subject
3) Subject with untreated decayed teeth
4) Subject with Sjogren syndrome
5) Subject with inflammatory disease
6) Subject with malignant disease
7) Subject using steroid drug
8) Subject using anticholinergic agent
9) Subject using antibacterial drug
10) Subject using xylitol chewing gum routinely
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Yamashita
Organization Kyushu University Faculty of Dental Science
Division name Section of Preventive and Public Health Dentistry
Zip code
Address 3-1-1 Maidashi, Higashiku, Fukuoka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyushu University Faculty of Dental Science
Division name Section of Preventive and Public Health Dentistry
Zip code
Address
TEL
Homepage URL
Email shima@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Faculty of Dental Science
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 15 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
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 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
2012 Year 05 Month 15 Day
Last modified on
2012 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009371

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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