UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061294 |
|---|---|
| Receipt number | R000070135 |
| Scientific Title | Evaluation of the inhibitory effect of beta-glucan-containing dentifrice on cariogenic bacteria: A clinical study |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/17 18:27:05 |
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Basic information
Public title
Effects of a toothpaste containing beta-glucan on oral bacteria count
Acronym
Effect of beta-glucan toothpaste on oral bacteria
Scientific Title
Evaluation of the inhibitory effect of beta-glucan-containing dentifrice on cariogenic bacteria: A clinical study
Scientific Title:Acronym
BG-Dentifrice Study
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of a beta-glucan-containing dentifrice in modulating oral bacterial counts among healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Counts of mutans streptococci and Lactobacillus species in saliva
2. Total number of salivary cariogenic bacteria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
beta-glucan-containing toothpaste group: Subjects will perform routine toothbrushing with the co-developed toothpaste containing beta-glucan for routine toothbrushing twice daily for 1 week.
Interventions/Control_2
Control toothpaste group (Placebo group): Subjects will perform toothbrushing under the same conditions as the intervention group, using a control toothpaste (placebo) that does not contain beta-glucan.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Male or female adults aged 18 years or older at the time of informed consent.
2. Subjects with clinically healthy gingiva.
3. Subjects who understand the study purpose and provide written informed consent.
Key exclusion criteria
1. Subjects with dental caries (excluding teeth requiring observation), gingivitis, or periodontitis.
2. Subjects who have taken antibiotics or anti-inflammatory drugs within the past month.
3. Current smokers.
4. Subjects currently undergoing dental treatment.
5. Regular users of electric toothbrushes.
6. Other individuals judged to be inappropriate for participation by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Ariyoshi |
Organization
Kyushu Dental University
Division name
Division of Infections and Molecular Biology, Department of Advanced Pathophysiological Science
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
093-285-3052
arikichi@kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Ariyoshi |
Organization
Kyushu Dental University
Division name
Division of Infections and Molecular Biology, Department of Advanced Pathophysiological Science
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
093-285-3052
Homepage URL
arikichi@kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Wataru Ariyoshi
Funding Source
Organization
Kyushu Dental University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
SHABONDAMA SOAP Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kyushu Dental University
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
Tel
093-582-1131
gakusei@kyu-dent.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
九州歯科大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070135
