UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035510 |
|---|---|
| Receipt number | 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 22:28:39 |
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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
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
natsuki@kk.iij4u.or.jp
Sponsor or person
Institute
Fujiwara Dental Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040460
