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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033906
Receipt No. R000038643
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.
Date of disclosure of the study information 2018/08/27
Last modified on 2019/02/26

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Basic information
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
Condition oral environment
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Fukuoka Dental College
Institute
Department

Funding Source
Organization Wakamoto Pharmaceutical Co.
Organization
Division
Category of Funding Organization Profit 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
2018 Year 08 Month 27 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 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
Other related information

Management information
Registered date
2018 Year 08 Month 27 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038643

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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