UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of tablets containing Lactobacillus salivarius WB21 and hinokitiol on inflammation of gingiva, subjective symptoms in oral cavity, and numbers of bacteria in saliva.
Title of the study (Brief title)	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	Takao Hirofuji
Organization	Fukuoka Dental College
Division name	Department of General Dentistry
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	Nao Taniguchi
Organization	Fukuoka Dental College
Division name	Department of Preventive and Public Health Dentistry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000038643