UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054504 |
|---|---|
| Receipt number | R000062272 |
| Scientific Title | Evaluation of inhibitory effects of saliva on viral infections by tooth brushing |
| Date of disclosure of the study information | 2024/05/29 |
| Last modified on | 2024/05/29 17:35:34 |
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Basic information
Public title
Evaluation of inhibitory effects of saliva on viral infections by tooth brushing
Acronym
Evaluation of inhibitory effects of saliva on viral infections by tooth brushing
Scientific Title
Evaluation of inhibitory effects of saliva on viral infections by tooth brushing
Scientific Title:Acronym
Evaluation of inhibitory effects of saliva on viral infections by tooth brushing
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of inhibitory effects of saliva on viral infections by tooth brushing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the inhibitory effect of saliva on influenza virus cell infection before and after tooth brushing.
Key secondary outcomes
1. Evaluation of saliva before and after tooth brushing.
(1) Inhibitory effect of saliva on the interaction between the SARS-CoV-2 spike protein and ACE2.
(2) Concentration of IgA binding to SARS-CoV-2 and total IgA.
(3) Salivary test data including cariogenic bacteria level, acidity, buffer capacity, leukocyte level, protein level, and ammonia level.
2. Oral examination including Decayed, missing, and filled teeth, probing depths, and bleeding on probing and survey of lifestyle habit.
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.
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
Subjects who brush their teeth at least twice a day using a toothbrush and toothpaste.
Subjects who brush their teeth after dinner and before bedtime.
Subjects who have at least 20 teeth remaining.
Subjects who collect the necessary amount of saliva for evaluation (>600uL).
Subjects who have given voluntary consent in writing to participate in the study.
Key exclusion criteria
Subjects who are planning to undergo dental treatment during the study period.
Subjects who are planning to participate in oral care-related studies during the study period.
Subjects undergoing orthodontic treatment.
Subjects who are using bridges, dentures, or implants.
Subjects who are diagnosed to have caries (Score 1 or higher).
Subjects who are diagnosed with periodontal probing depth of 4mm or more and bleeding on probing.
Subjects who have taken antibiotics within the past 3 months.
Subjects who smoke.
Subjects who regularly drink alcohol more than 5 days a week, exceeding 40g/day for males and 20g/day for females.
Subjects who have been diagnosed by a physician as having blood disorders (aplastic anemia, etc.), infectious diseases (varicella, cytomegalovirus infection, measles, infectious mononucleosis), diabetes, renal disease, liver disease, chronic gastritis, colitis, lupus erythematosus, cancer, immune deficiency disease, alcohol dependence, or undernutrition.
Subjects who are currently pregnant or have the possibility of pregnancy.
Any other 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 | Kei |
| Middle name | |
| Last name | Kurita |
Organization
Lion corporation
Division name
Advanced oral health science research laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
03-3616-3796
kei-k@lion.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Kurita |
Organization
Lion corporation
Division name
Advanced oral health science research laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
03-3616-3796
Homepage URL
kei-k@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
mukkaz@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
ライオン株式会社平井研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
16
Results
The amount of ammonia decreased after tooth brushing. Additionally, the salivary inhibitory effects on influenza virus cell infection increased after tooth brushing. Moreover, the salivary inhibitory effects of the interaction between the SARS-CoV-2 spike protein and ACE2 increased after tooth brushing.
Results date posted
| 2024 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No oral diseases such as caries and periodontal disease.
Participant flow
(1) Obtained consent and conducted screening evaluation by dental checkup for 26 subjects.
(2) Excluded 9 subjects who met the exclusion criteria and conducted main evaluation of 17 subjects.
(3) After completion of the main evaluation, one subject who was confirmed to meet the exclusion criteria was excluded from the analysis, and data analysis was conducted for 16 subjects.
Adverse events
One subject reported common cold symptoms one time from the day after the screening evaluation. The subject was later confirmed to have recovered completely and the main evaluation was conducted. The physician determined that this case had "no causal relationship" to the study.
Outcome measures
The amount of ammonia decreased after tooth brushing. Additionally, the salivary inhibitory effects on influenza virus cell infection increased after tooth brushing. Moreover, the salivary inhibitory effects of the interaction between the SARS-CoV-2 spike protein and ACE2 increased after tooth brushing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062272
