UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013160 |
|---|---|
| Receipt number | R000015344 |
| Scientific Title | The effect of tablet containing Lactic acid bacteria on caries risk factor |
| Date of disclosure of the study information | 2014/02/14 |
| Last modified on | 2014/02/14 13:35:30 |
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Basic information
Public title
The effect of tablet containing Lactic acid bacteria on caries risk factor
Acronym
The caries inhibition of tablet containing Lactic acid bacteria
Scientific Title
The effect of tablet containing Lactic acid bacteria on caries risk factor
Scientific Title:Acronym
The caries inhibition of tablet containing Lactic acid bacteria
Region
| Japan |
Condition
Condition
dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of the tablet containing Lactobacillus salivarius WB21 (Minnanozendamakin WB21 Tablet, Wakamoto Pharmaceutical Co., Tokyo, Japan) on caries risk is evaluated by comparing with other products.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of mutans streptococci, Level of Lactobacilli, salivary flow rate, salivary pH, buffer capacity of saliva
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
tablet containing Lactobacillus salivarius WB21
Interventions/Control_2
tablet containing Lactobacillus salivarius LS1
Interventions/Control_3
tablet containing Ovalgen DC
Interventions/Control_4
tablet containing xyltol
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 23 | years-old | <= |
Age-upper limit
| 31 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
adult volunteers without systemic disease
Key exclusion criteria
under dental treatment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nao Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of General Dentistry
Zip code
Address
2-15-1, Tamura, Sawara-ku, Fukuoka
TEL
81-92-801-0411
naojsz@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taniguchi Nao |
Organization
Fukuoka Dental College
Division name
Department of General Dentistry
Zip code
Address
2-15-1, Tamura, Sawara-ku, Fukuoka
TEL
81-92-801-0411
Homepage URL
naojsz@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Dental College
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 02 | Month | 14 | 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
Oral administration of L. salivarius WB21 tablet reduced levels of mutans streptococci compared to that of xylitol tablet. Oral administration of L. salivarius LS1 tablet increased salivary rate and salivary buffering capacity compared to xylitol tablet. Moreover, saliva pH was not reduced after taking in both tablets containing lactobacilli. In conclusion, those data indicated that the tablets containing lactobacilli have resistive effect to caries risks.
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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | 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
| 2014 | Year | 02 | Month | 14 | Day |
Last modified on
| 2014 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015344
