UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059490 |
|---|---|
| Receipt number | R000068034 |
| Scientific Title | Effects of Alkaline Ionized Water Gargling on Streptococcus mutans Levels and Salivary Properties |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/21 16:25:07 |
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Basic information
Public title
A Study on the Effects of Gargling with Alkaline Ionized Water on Salivary Levels of Caries-Causing Bacteria
Acronym
Alkaline Ionized Water - Caries Bacteria Study
Scientific Title
Effects of Alkaline Ionized Water Gargling on Streptococcus mutans Levels and Salivary Properties
Scientific Title:Acronym
Alkaline Ionized Water - Streptococcus Mutans Study
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of gargling with alkaline ionized water on the oral environment of healthy adults, with a particular focus on changes in salivary Streptococcus mutans levels.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in salivary Streptococcus mutans levels before and after a 30-day gargling intervention with alkaline ionized water.
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
| Food |
Interventions/Control_1
Participants will gargle with alkaline ionized water three times daily, immediately after each meal (breakfast, lunch, and dinner), for a total of 30 consecutive days. Each gargling session will last approximately 30 seconds. The total daily amount of alkaline ionized water used is 500 milliliters.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Twenty functional teeth or more.
Able to provide written informed consent.
Key exclusion criteria
Known allergy or hypersensitivity to any mineral components in alkaline ionized water.
Medical conditions contraindicating gargling (e.g., dysphagia or severe oral dysfunction).
Ongoing dental treatment for active caries or other oral diseases that may affect study assessments.
Concurrent participation in other oral health programs or clinical studies that may influence the results of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Sato |
Organization
Tokai University School of Medicine
Division name
Division of Basic Medical Science,
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
+81-463-93-1121(2513)
b-sato2@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Suzuki |
Organization
The Nippon Dental University College at Tokyo
Division name
Department of Dental Hygiene
Zip code
162-0815
Address
2-3 Tsukudo-Hachiman, Shinjuku-ku, Tokyo
TEL
+81-3-3266-5063
Homepage URL
megumi-t@tandai.ndu.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Tsutomu Sato
Funding Source
Organization
Association of Alkaline Ionized Water Apparatus
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tsurumi University School of Dental Medicine
Address
2-1-3 Tsurumi, Yokohama, Japan
Tel
+81-45-580-8205
kyoken@tsurumi-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
| 2025 | Year | 10 | Month | 21 | 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
30
Results
The 30-day AIW mouth-rinsing intervention resulted in a statistically significant decrease in salivary S. mutans levels (P < 0.01; Wilcoxon signed-rank test). The median Dentocult SM score decreased from Score 2 to Score 1, and 70% of the participants showed a reduction in their S. mutans score category.
Results date posted
| 2025 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 30 healthy adult volunteers (16 male, 14 female; mean age: 42.6 years; range: 24-66 years) were enrolled. All participants had at least 24 functional teeth.
Participant flow
Participants were first screened for eligibility and provided written informed consent. Baseline saliva samples were collected prior to the intervention. Each participant then performed gargling with alkaline ionized water three times daily after meals for 30 consecutive days. After the intervention period, saliva samples were collected again, and adherence records and adverse events were reviewed. The study was completed following final evaluations.
Adverse events
None.
Outcome measures
Primary Outcome: Change in salivary Streptococcus mutans levels after a 30-day alkaline ionized water mouth-rinsing intervention.
Measurement method: Dentocult SM Strip Mutans kit (Orion Diagnostica, Finland), scored on a 4-point ordinal scale.
Results: 70% of participants (21/30) showed a reduction in score category. Median score decreased from Score 2 at baseline to Score 1 post-intervention. Wilcoxon signed-rank test showed a significant reduction (P < 0.01).
Plan to share IPD
Plan to share individual participant data.
IPD sharing Plan description
The individual participant data IPD collected during the clinical trial will not be publicly available due to patient privacy regulations and restrictions imposed by the Institutional Ethics Committees. However, de-identified data may be made available upon reasonable request to the Principal Investigator, provided that the request complies with ethical guidelines and institutional approval.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068034
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/10/22 | Clinical protocol (AIW).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/10/22 | Data specification (AIW) ver. 2.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/10/22 | Data (AIW).xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/68034
