UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061152 |
|---|---|
| Receipt number | R000069978 |
| Scientific Title | Evaluation of the salivary antiviral mechanism induced by tooth brushing |
| Date of disclosure of the study information | 2026/04/03 |
| Last modified on | 2026/04/03 14:34:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the salivary antiviral mechanism induced by tooth brushing
Acronym
Evaluation of the salivary antiviral mechanism induced by tooth brushing
Scientific Title
Evaluation of the salivary antiviral mechanism induced by tooth brushing
Scientific Title:Acronym
Evaluation of the salivary antiviral mechanism induced by tooth brushing
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the mechanism of the inhibitory effects of saliva on viral infection by tooth brushing, using information and samples obtained from the prior trial (UMIN000054504) for secondary use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Salivary IgA concentration, defensin concentration, and oral bacterial flora before and after tooth brushing.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Brushing teeth with toothpaste for 5 minutes. (Intervention methods described in the prior trial)
Interventions/Control_2
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
Subject for whom the necessary amount of saliva and bacterial DNA extracted from mouth rinsed water are available for conducting the test.
Key exclusion criteria
Subject who, in the opinion of the principal investigator, is not suitable for the study.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Riichi |
| Middle name | |
| Last name | Maki |
Organization
Lion corporation
Division name
Life Science Laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
03-3616-3796
makir@lion.co.jp
Public contact
Name of contact person
| 1st name | Riichi |
| Middle name | |
| Last name | Maki |
Organization
Lion corporation
Division name
Life Science Laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
03-3616-3796
Homepage URL
makir@lion.co.jp
Sponsor or person
Institute
Lion corporation
Institute
Department
Personal name
Funding Source
Organization
Lion 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
Institutional Review Board of Lion corporation
Address
1-3-28, Kuramae, Taito-ku, Tokyo, Japan
Tel
03-6739-3711
tohki@lion.co.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 | 04 | Month | 03 | 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 | 27 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069978
