UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062196 |
|---|---|
| Receipt number | R000071175 |
| Scientific Title | Efficacy Verification Test for Cleaning Effect of Toothpaste NP214 |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/10 08:47:25 |
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Basic information
Public title
Examination of the cleaning effect of continuous toothpaste use
Acronym
Examination of the cleaning effect of toothpaste
Scientific Title
Efficacy Verification Test for Cleaning Effect of Toothpaste NP214
Scientific Title:Acronym
Efficacy Verification Test for Cleaning Effect of Toothpaste
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the Cleaning effect of toothpaste NP214
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of tongue bacteria after toothpaste use
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use toothpaste NP214 over 2 times a day for 2 weeks
Interventions/Control_2
Use placebo toothpaste over 2 times a day for 2 weeks
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Human aged 20-59
Key exclusion criteria
1. Individuals with severe allergies or other drug hypersensitivities
2. Individuals with one of the five major diseases (cancer, stroke, acute myocardial infarction, diabetes, or mental illness) who are currently undergoing treatment at a medical facility or are scheduled for surgery or other
procedures
3. Pregnant women, women who may be pregnant, or women who are breastfeeding
4. Individuals who have taken antibiotics within the past 3 months
5. Individuals currently participating in other human trials related to oral care or food intake trials
6. Individuals who have had a tooth extracted or undergone dental surgery within the past 3 months
7. Individuals currently receiving oral treatment at a dental clinic
8. Individuals with five or more missing teeth at the time of enrollment (excluding wisdom tooth extractions and
extractions due to orthodontic treatment)
9. Individuals with visible oral trauma at the time of enrollment
10. Individuals with severe gingivitis at the time of recruitment
11. Individuals who smoke one or more cigarettes per day at the time of recruitment
12. Individuals who clean their tongue at least once a month at the time of recruitment
13. Individuals deemed unsuitable as study participants by the principal investigator due to violations of compliance obligations or other reasons"
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Nakatsu |
Organization
Kao Corporation
Division name
Human Healthcare Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8669
nakatsu.susumu@kao.com
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Tajikara |
Organization
Kao Corporation
Division name
Human Healthcare Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3301-1418
Homepage URL
tajikara.teppei@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 07 | Month | 15 | 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 | 07 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | 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 | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071175
