UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062133 |
|---|---|
| Receipt number | R000071096 |
| Scientific Title | Evaluation tests for oral composition 20260528 |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/07/03 14:37:18 |
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Basic information
Public title
The test of the toothpaste
Acronym
The test of the toothpaste
Scientific Title
Evaluation tests for oral composition 20260528
Scientific Title:Acronym
Evaluation tests for new oral composition
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the oral composition 20260528.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical attachment level of the periodontal tissue before and after 12wks application
Key secondary outcomes
Gingival index
Bleeding on probing index
Probing pocket depth
Recession
RNA expression in the alveolar mucosa
Protein expression in the alveolar mucosa
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Brush teeth at least twice a day using oral care product 20260528 for 12wks.
Interventions/Control_2
Brush teeth at least twice a day using placebo for 12wks.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Men and women aged 40 to 65
-People who meet either criterion 1 or 2 below, and also meet any one of criteria 3, 4, or 5
1. You feel like your gums have receded and your teeth have become longer
2. You feel like food gets stuck between your teeth
3.Your gums sometimes bleed when you brush your teeth
4. Your gums sometimes swell
5. You have been told that your gums are swollen or that your periodontal pockets are deep
-People who have 20 or more of their own teeth
-People who brush their teeth at least twice a day
Key exclusion criteria
-People with diabetes, heart disease, kidney disease, liver disease, or other conditions that affect overall bodily function
-Individuals taking medication prescribed by a doctor for a medical condition (excluding allergy medication)
-Individuals currently receiving medical treatment for oral conditions other than periodontal disease
-Individuals currently undergoing treatment for periodontal disease
-Individuals currently undergoing orthodontic treatment
-Individuals with loose teeth
-Individuals who have undergone dental implant treatment
-Individuals who visit the dentist regularly at least three times a year
-Women who are pregnant or plan to become pregnant during the study period
-Smokers
-Individuals who are already participating in another study at the time of the study briefing, or who plan to participate in another study during the period of participation in this study
-Individuals or their household members who are employed by advertising agencies, research or consulting firms, media, or the manufacturing or distribution of health foods, cosmetics, toiletries, or hygiene products
-Any other individuals deemed unsuitable for study participation by study personnel
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Okumura |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-07-3300-8697
okumura.aya@kao.com
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Sato |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-07-3300-8718
Homepage URL
satou.kayo2@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 | 09 | 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 | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 25 | 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 | 03 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071096
