UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003112 |
|---|---|
| Receipt number | R000003777 |
| Scientific Title | A longitudinal study about Xylitol, its influence and preventive effectiveness on mutans streptococci and Streptococcus pneumoniae |
| Date of disclosure of the study information | 2010/01/28 |
| Last modified on | 2010/01/28 16:40:09 |
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Basic information
Public title
A longitudinal study about Xylitol, its influence and preventive effectiveness on mutans streptococci and Streptococcus pneumoniae
Acronym
Effect of Xylitol on oral bacteria
Scientific Title
A longitudinal study about Xylitol, its influence and preventive effectiveness on mutans streptococci and Streptococcus pneumoniae
Scientific Title:Acronym
Effect of Xylitol on oral bacteria
Region
| Japan |
Condition
Condition
dental caries, otitis media
Classification by specialty
| Pediatrics | Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the influence of xylitol consumption on the oral bacteria of preschool children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dentocult SM score development in the children observed at 0 and 6, and 9 months after the baseline survey.
Key secondary outcomes
PCR detection for Streptococcus pneumoniae in the children observed at 0 and 6, and 9 months after the baseline survey.
.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The children in Xylitol gum group were instructed to chew 1 gum pellet (100% xylitol gum) at least 4 times per day for three months (from months 6 to 9).
Interventions/Control_2
The children in control group were to be untreated for three months (from months 6 to 9).
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
| 3 | years-old | <= |
Age-upper limit
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We examined children who attended preschools in Tokyo, Japan. The preschools were within 2 km of one another.
Key exclusion criteria
Individual with a history of regular antibiotics medication or habitual xylitol gum consumption.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuko Seki |
Organization
Nihon University School of Dentistry
Division name
Oral Health Sciences
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8310, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuko Seki |
Organization
Nihon University School of Dentistry
Division name
Oral Health Sciences
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8310, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Oral Health Sciences, Nihon University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Uemura Fund, Nihon University School of Dentistry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Lotte Co., Ltd, Central Laboratory
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
| 2010 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2001 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 28 | Day |
Last modified on
| 2010 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003777
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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