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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035510
Receipt No. R000040460
Scientific Title Clinically controlled comparative study on plaque suppressive effect between L8020 lactic acid bacteria tablets and xylitol tablets for children
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/10

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Basic information
Public title Clinically controlled comparative study on plaque suppressive effect between L8020 lactic acid bacteria tablets and xylitol tablets for children
Acronym Clinically controlled comparative study on plaque suppressive effect between L8020 lactic acid bacteria tablets and xylitol tablets for children
Scientific Title Clinically controlled comparative study on plaque suppressive effect between L8020 lactic acid bacteria tablets and xylitol tablets for children
Scientific Title:Acronym Clinically controlled comparative study on plaque suppressive effect between L8020 lactic acid bacteria tablets and xylitol tablets for children
Region
Japan

Condition
Condition Dental caries
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the inhibitory effect of the tablet containing Lactobacillus rhamnosus L8020 and xylitol tablet.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dental plaque of one month after using L8020 lactic acid bacteria tablets or xylitol tablets every day
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Tablet containing Lactobacillus rhamnosus L8020
One month to use twice daily
Interventions/Control_2 Xylitol tablet
One month to use twice daily
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
4 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Visiting patients of Fujiwara dental clinic
Key exclusion criteria Patients unable to take tablet orally
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Natsuki Fujiwara
Organization Fujiwara Dental Clinic
Division name Fujiwara Dental Clinic
Zip code
Address Nakasuji3-29-23 FururiruOkinishi2F, Asaminami-ku, Hiroshima-city
TEL 082-830-5300
Email natsuki@kk.iij4u.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Natsuki Fujiwara
Organization Fujiwara Dental Clinic
Division name Fujiwara Dental Clinic
Zip code
Address Nakasuji3-29-23 FururiruOkinishi2F, Asaminami-ku, Hiroshima-city
TEL 082-830-5300
Homepage URL
Email natsuki@kk.iij4u.or.jp

Sponsor
Institute Fujiwara Dental Clinic
Institute
Department

Funding Source
Organization Fujiwara Dental Clinic
Organization
Division
Category of Funding Organization Self funding
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 ふじわら歯科医院(広島県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 11 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 Completed
Date of protocol fixation
2018 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
2018 Year 08 Month 20 Day
Date of closure to data entry
2018 Year 08 Month 20 Day
Date trial data considered complete
2018 Year 08 Month 29 Day
Date analysis concluded
2018 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 10 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040460

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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