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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name