UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055130 |
|---|---|
| Receipt number | R000062984 |
| Scientific Title | Ingestion test of the oral components T0212_2024 |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/08/04 11:44:45 |
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Basic information
Public title
Efficacy test of the oral components
Acronym
Efficacy test of the oral components
Scientific Title
Ingestion test of the oral components T0212_2024
Scientific Title:Acronym
Efficacy test of the oral components
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the inhibitory effect of oral care food on plaque formation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of plaque
Key secondary outcomes
Halitosis
Bacterial ratios in saliva, dental plaque, and tongue coating
Questionnaire
Gingival inflammation
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
| Food |
Interventions/Control_1
Ingest oral components T0212 3 times a day for 8 weeks
Interventions/Control_2
Ingest placebo 3 times a day for 8 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
2. Person agrees to use the designated toothpaste and toothbrush and to consume the test product during the study period (Interdental brushes and dental floss may be used, mouthwash or liquid toothpaste other than the designated dentifrice may not be used)
Key exclusion criteria
1. Person who are hypersensitive to drugs such as allergies
2. Person who have five major diseases (cancer, stroke, acute myocardial infarction, diabetes, mental illness), etc. and are being treated at a medical institution, or who are scheduled for surgery, etc.
3. Pregnant women, those who may be pregnant, or those who are breastfeeding
4. Person who have taken antibiotics within three month
5. Person who are currently participating in clinical trials related to other oral cavities and food ingestion
6. Person who have had teeth extraction other than wisdom teeth performed or dental surgery within the past 3 months
7. Person who are currently visiting a dental clinic and receiving oral treatment
8. Person who have more than 5 missing teeth (excluding wisdom tooth extraction and extraction due to orthodontics)
9. Person who have obvious trauma in the oral cavity
10. Person who have severe gingival inflammation
11. Person who have a habit of smoking at least one cigarette per day
12. Other persons who are judged by the dentist in charge of the test or the person in charge of the study to be inappropriate as a participant in the study
Target sample size
50
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
+81-3-5630-9747
nakatsu.susumu@kao.com
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Tsurumi |
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
+81-3-5630-9747
Homepage URL
tsurumi.rina2@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
| 2024 | Year | 08 | 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
47
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062984
