UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062087 |
|---|---|
| Receipt number | R000071002 |
| Scientific Title | Efficacy study on the effects of erythritol-containing gel application after toothbrushing on oral bacteria |
| Date of disclosure of the study information | 2026/06/29 |
| Last modified on | 2026/06/29 10:37:15 |
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Basic information
Public title
Efficacy study on the effects of erythritol-containing gel application after toothbrushing on oral bacteria
Acronym
Efficacy study on the effects of erythritol-containing gel application after toothbrushing on oral bacteria
Scientific Title
Efficacy study on the effects of erythritol-containing gel application after toothbrushing on oral bacteria
Scientific Title:Acronym
Efficacy study on the effects of erythritol-containing gel application after toothbrushing on oral bacteria
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the oral environment-improving effect of a single application of erythritol-containing gel after regular toothbrushing before bedtime, compared with non-application, in a crossover study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral bacterial test via saliva collection on the morning of Day 2 (immediately after waking up) in Period 1 and Period 2.
Key secondary outcomes
Oral questionnaire on subjective symptoms before bedtime (after treatment) on Day 1 and immediately after waking up (at the time of saliva collection) on Day 2 in each period.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Group I: In Period 1, a single application of approximately 15 g of the test food (5% erythritol-containing gel, equivalent to 0.5-0.8 g of erythritol) into the oral cavity after regular toothbrushing before bedtime. Following a 1-week washout period, Period 2 consists of non-application of the product (regular toothbrushing only).
Interventions/Control_2
Group II: In Period 1, non-application of the product (regular toothbrushing only). Following a 1-week washout period, Period 2 consists of a single application of approximately 15 g of the test food (5% erythritol-containing gel, equivalent to 0.5-0.8 g of erythritol) into the oral cavity after regular toothbrushing before bedtime.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Japanese male or female aged 18 years old or more and under 70 years old at the time of obtaining consent.
3. Persons who do not have an allergy to artificial sweeteners such as erythritol.
4. Persons who do not suffer from diseases related to the oral cavity, teeth, or gums (not diagnosed with alveolar pyorrhea or periodontal disease), and feel concerned about their oral environment but are judged not to need immediate treatment.
Key exclusion criteria
1. Persons who are diagnosed with oral diseases such as alveolar pyorrhea or periodontal disease, or who are scheduled for dental treatment on the day of the study.
2. Persons who routinely use (3 days or more per week) products containing artificial sweeteners such as erythritol, or who have routinely used them within 3 months prior to the pre-examination.
3. Persons who are diagnosed with malignant tumor, or who are undergoing treatment for cranial nerve disease, heart disease, kidney disease, diabetes, or thyroid dysfunction, or who have a history of serious diseases such as liver disease. (However, diseases such as hypertension treatment which the principal investigator judges not to affect the evaluation of this study are excluded.)
4. Persons who consume a large amount of alcohol (60 g or more of alcohol per day: equivalent to approximately 1500 mL of beer, 540 mL of wine, 3 go of sake, or 180 mL of double whiskey).
5. Persons who may develop an allergic reaction related to the study product.
6. Persons who are judged to be inappropriate as a study subject based on their response to the background survey.
7. Persons who have participated in another clinical study within 1 month before obtaining consent for this study, or who plan to participate in another clinical study after consenting to this study.
8. Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
9. Persons who are otherwise judged as inappropriate for study participants by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosys Lab Co., Ltd.
Division name
CEO
Zip code
470-1192
Address
11-506, 1-98, Dengagakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosys Lab Co., Ltd.
Division name
CEO
Zip code
470-1192
Address
11-506, 1-98, Dengagakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
Biosys Lab Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASPAC Enterprise Co., Ltd.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2026 | Year | 06 | Month | 29 | 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 | 05 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071002
