UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033906 |
|---|---|
| Receipt number | 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 09:15:43 |
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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
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
naojsz@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038643
