UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059245 |
|---|---|
| Receipt number | R000067763 |
| Scientific Title | Examination of the effects of consuming a food containing lactic acid bacteria WB21 and epigallocatechin gallate (Avantbise Oral Tablets) on gingival condition and microorganisms in tongue coating |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/09/30 17:36:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effects of a food containing lactic acid bacteria WB21 and catechin (Avantbise Oral Tablets) on gingival condition and microorganisms in tongue coating
Acronym
Effects of a food containing lactic acid bacteria WB21 and catechin on gingival condition and microorganisms in tongue coating
Scientific Title
Examination of the effects of consuming a food containing lactic acid bacteria WB21 and epigallocatechin gallate (Avantbise Oral Tablets) on gingival condition and microorganisms in tongue coating
Scientific Title:Acronym
Examination of the effects of consuming a food containing lactic acid bacteria WB21 and epigallocatechin gallate on gingival condition and microorganisms in tongue coating
Region
| Japan |
Condition
Condition
gingival condition
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the continuous intake of food containing lactic acid bacteria WB21, which has been reported to be useful in maintaining oral health, and epigallocatechin gallate, which is expected to have various physiological functions such as antioxidant and deodorizing effects, is effective in maintaining and promoting gingival health and oral flora in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gingival health
Key secondary outcomes
Microbial balance on tongue coating
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
Study participants were asked to lick three tablets of a food product containing Lactobacillus salivarius WB21 and epigallocatechin gallate (Avantbise Oral Tablets) daily, one tablet at a time, after meals and after brushing their teeth.
Interventions/Control_2
Study participants were asked to lick three tablets of a placebo containing no Lactobacillus salivarius WB21 or epigallocatechin gallate daily, one tablet at a time, after meals and after brushing their teeth.
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 adult men and women
(2) Those who brush their teeth at least twice a day
(3) Those with 20 or more teeth
Key exclusion criteria
(1) Subjects with any oral symptoms
(2) Subjects who regularly smoke
(3) Subjects who wear dentures
(4) Subjects who have received periodontal treatment within 3 months prior to the start of the study
(5) Subjects who have taken antibiotics within 3 months prior to the start of the study
(6) Subjects who have used toothpaste, mouthwash, or oral care supplements containing lactic acid bacteria within 1 month prior to the start of the study
(7) Subjects with a history of digestive disorders (gastritis, gastric ulcer, colitis, etc.), diabetes, liver disease, kidney disease, serious respiratory disorders such as asthma, serious heart disease, or systemic disorders such as malignant tumors
(8) Subjects who are or may be pregnant, or who are breastfeeding
(9) Subjects with a history of milk allergies or food allergies to food ingredients
(10) Subjects who are otherwise deemed inappropriate participants by the study director
(11) Subjects who have participated in other clinical trials within 1 month prior to obtaining consent to participate in this study, or who plan to participate in other clinical trials after obtaining consent to participate in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of Preventive and Public Health Dentistry
Zip code
8140175
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
81-92-801-0616
naojsz@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of Preventive and Public Health Dentistry
Zip code
8140175
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
81-92-801-0616
Homepage URL
naojsz@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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakamoto Pharmaceutical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Gakuen Ethics Committee
Address
2-15-1, Tamura, Sawara-ku, Fukuoka, Japan
Tel
81-92-801-0425
shomu@fdcnet.ac.jp
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
| 2025 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067763
