UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061402 |
|---|---|
| Receipt number | R000070205 |
| Scientific Title | Comprehensive analysis of the effects of chlorhexidine-containing mouthwash on oral bacteria. |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/28 13:25:27 |
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Basic information
Public title
Comprehensive analysis of the effects of chlorhexidine-containing mouthwash on oral bacteria.
Acronym
Comprehensive analysis of the effects of chlorhexidine-containing mouthwash on oral bacteria.
Scientific Title
Comprehensive analysis of the effects of chlorhexidine-containing mouthwash on oral bacteria.
Scientific Title:Acronym
Comprehensive analysis of the effects of chlorhexidine-containing mouthwash on oral bacteria.
Region
| Japan |
Condition
Condition
Oral disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of mouthwash use on number of oral bacteria and the oral microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of oral bacteria, including S. mutans at the start of study and at the end of use of each mouthwash.
Key secondary outcomes
Plaque accumulation, periodontal condition, oral microbiota
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
After saliva collection and dental check up, participants gargle with chlorhexidine-containing mouthwash three times a day (morning, noon, and night) for about one to two weeks. They receive the saliva collection and dental checkup again.
Interventions/Control_2
After saliva collection and dental check up, participants gargle with fluoride mouthwash three times a day (morning, noon, and night) for about one to two weeks. They receive the saliva collection and dental checkup again.
Interventions/Control_3
After saliva collection and dental check up, participants gargle with water three times a day (morning, noon, and night) for about one to two weeks. They receive the saliva collection and dental checkup again.
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 20 to 49 at the time of obtaining consent.
2. Individuals in good health who are not at risk of accidental ingestion or aspiration when using mouthwash.
3. Individuals who can provide written consent to participate in this study.
Key exclusion criteria
1. Individuals who have been taking medications or supplements for a long period or on a continuous basis up to the time of obtaining consent.
2. Individuals at risk of hypersensitivity to mouthwash.
3. Others deemed unsuitable by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Akitomo |
Organization
Hiroshima university
Division name
Department of Pediatric Dentistry, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5698
takitomo@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Akitomo |
Organization
Hiroshima university
Division name
Department of Pediatric Dentistry, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5698
Homepage URL
takitomo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
Weltec 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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2026 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 05 | 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
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070205
