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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003112
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Oral Health Sciences, Nihon University School of Dentistry
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003777

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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