UMIN-CTR Clinical Trial

Public title

Effects of tablets containing Lactobacillus salivarius WB21 and hinokitiol on inflammation of gingiva, subjective symptoms in oral cavity, and numbers of bacteria in saliva.

Acronym

Effects of tablets containing Lactobacillus salivarius WB21 and hinokitiol on oral environment.

Scientific Title

Effects of tablets containing Lactobacillus salivarius WB21 and hinokitiol on inflammation of gingiva, subjective symptoms in oral cavity, and numbers of bacteria in saliva.

Scientific Title:Acronym

Effects of tablets containing Lactobacillus salivarius WB21 and hinokitiol on oral environment.

Region

Japan

Condition

oral environment

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To develop new food product that improve oral environment, effects of intake of tablets containing Lactobacillus salivarius WB21 and hinokitiol for 4 weeks on inflammation of gingiva, subjective oral symptoms, and numbers of bacteria in saliva are assessed in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

modified gingival index (2 weeks and 4 weeks after starting ingestion)

Key secondary outcomes

subjective oral symptoms (2 weeks and 4 weeks after starting ingestion)
numbers of bacteria in saliva (2 weeks and 4 weeks after starting ingestion)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The participants in the test group ingest tablets containing Lactobacillus salivarius WB21 and hinokitiol for 4 weeks. The dose is maintained at 1 tablet 3 times a day, taken orally after eating and mouth cleaning.

Interventions/Control_2

The participants in the placebo group ingest placebo tablets. The dose is maintained at 1 tablet 3 times a day, taken orally after eating and mouth cleaning.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy adults.
2. Brushing teeth twice a day using only toothbrush.
3. Average of modified gingival index is equal to or more than0.5.
4. Having something subjective symptoms in questionnaire about subjective symptoms in the oral cavity.

Key exclusion criteria

1. A person diagnosed as suffering from any dental disease by a dentist.
2. Person who underwent periodontal treatment or treatment with antibacterial agent within 3 months prior to the start of the study.
3. Persons who received maintenance such as dental plaque and calculus removal at the dental office within 3 months prior to the start of the test.
4. Smokers.
5. Persons using dentures.
6. Persons who used lactic acid bacteria-containing dentifrice, mouthwash and oral care supplement within 1 month prior to the start of the test.
7. Persons who have a history of systemic diseases such as gastrointestinal disease (gastritis, stomach ulcer, colitis, etc), severe respiratory diseases such as diabetes, liver disease, kidney disease, asthma, severe heart disease, malignant tumor.
8. Milk and hinokitiol allergies.
9. Pregnant or possibly pregnant or breast-feeding.
10. Those who have participated in other clinical trials within one month prior to agree participation or those who intend to participate in other clinical trials after obtaining participation agreement for this study.
11. Persons who judged that the investigator is inappropriate as the subject.

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Takao Hirofuji

Organization

Fukuoka Dental College

Division name

Department of General Dentistry

Zip code

Address

2-15-1, Tamura, Sawara-ku, Fukuoka 814-0193, Japan

TEL

092-801-0411

Email

hirofuji@college.fdcnet.ac.jp

Name of contact person

1st name
Middle name
Last name	Nao Taniguchi

Organization

Fukuoka Dental College

Division name

Department of Preventive and Public Health Dentistry

Zip code

Address

2-15-1, Tamura, Sawara-ku, Fukuoka 814-0193, Japan

TEL

092-801-0411

Homepage URL

Email

naojsz@college.fdcnet.ac.jp

Institute

Fukuoka Dental College

Institute

Department

Personal name

Organization

Wakamoto Pharmaceutical Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

05

Month

30

Day

Date of IRB

Anticipated trial start date

2018

Year

08

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

08

Month

27

Day

Last modified on

2019

Year

02

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038643