UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056101 |
|---|---|
| Receipt number | R000064101 |
| Scientific Title | Bactericidal effect of toothpaste containing silver ion against oral pathogens |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/11/08 14:52:15 |
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Basic information
Public title
Bactericidal effect of toothpaste containing silver ion against oral pathogens
Acronym
Bactericidal effect of toothpaste containing silver ion against oral pathogens
Scientific Title
Bactericidal effect of toothpaste containing silver ion against oral pathogens
Scientific Title:Acronym
Bactericidal effect of toothpaste containing silver ion against oral pathogens
Region
| Japan |
Condition
Condition
Dental caries, chronic periodontitis, oral candidiasis, opportunistic infections caused by staphylococci
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the bactericidal effect of commercial silver ion toothpastes on oral pathogens over time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects will be randomly assigned to either a group using two toothpastes containing silver ions or a group using a toothpaste without silver ions. To evaluate the bactericidal effect of silver ions, the proportions of various oral pathogens in saliva will be assessed through culture testing on selective media before toothpaste use and at 30, 90, and 180 days after starting use.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will be instructed to use a commercially available silver ion toothpaste (SMILE YOU) freely during their regular brushing routine for a continuous period of 180 days.
Interventions/Control_2
Participants will be instructed to use a commercially available silver ion toothpaste (SMILE ONE) freely during their regular brushing routine for a continuous period of 180 days.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Able-bodied persons over 18 years old
Key exclusion criteria
Minors, pregnant women, those who have received antimicrobial agents within the past 6 months, those with systemic diseases, and those with xerostomia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Senpuku |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Microbiology and Immunology
Zip code
271-0061
Address
2-870-1 Sakaecho-Nishi, Matsudo-shi, Chiba-ken 271-0061 Japan
TEL
047-360-9336
senpuku.hidenobu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Senpuku |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Microbiology and Immunology
Zip code
271-0061
Address
2-870-1 Sakaecho-Nishi, Matsudo-shi, Chiba-ken 271-0061 Japan
TEL
047-6-360-9336
Homepage URL
senpuku.hidenobu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Pikasshu 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
Nihon University School of Dentistry at Matsudo
Address
2-870-1 Sakaecho-Nishi, Matsudo-shi, Chiba-ken 271-0061 Japan
Tel
047-368-6111
kj.md.ml@nihon-u.ac.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
| 2024 | Year | 12 | Month | 10 | 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
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 19 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064101
