UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007962 |
|---|---|
| Receipt number | 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 17:09:31 |
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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
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
shima@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Faculty of Dental Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009371
