UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060850 |
|---|---|
| Receipt number | R000069629 |
| Scientific Title | Evaluation of the effect of a single mouth rinse with a seaweed extract on periodontitis-related bacteria: A placebo-controlled, randomized, single-blind, parallel-group study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/30 09:05:16 |
* 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 effect of a single mouth rinse with a seaweed extract on periodontitis-related bacteria
Acronym
Evaluation of the effect of a single mouth rinse with a seaweed extract on periodontitis-related bacteria
Scientific Title
Evaluation of the effect of a single mouth rinse with a seaweed extract on periodontitis-related bacteria:
A placebo-controlled, randomized, single-blind, parallel-group study
Scientific Title:Acronym
Evaluation of the effect of a single mouth rinse with a seaweed extract on periodontitis-related bacteria:
A placebo-controlled, randomized, single-blind, parallel-group study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a single mouth rinse with a seaweed extract solution on oral periodontal disease-related bacteria in healthy Japanese men and women aged 20 to <65 years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Total salivary bacteria count and Porphyromonas gingivalis count at pre-rinse, 1 h post-rinse, and 4 h post-rinse
2. Proportion of salivary Porphyromonas gingivalis at 1 h and 4 h post-rinse relative to pre-rinse
3. Proportion of Porphyromonas gingivalis relative to total salivary bacteria at pre-rinse, 1 h post-rinse, and 4 h post-rinse
Key secondary outcomes
1. Counts of Tannerella forsythia and Treponema denticola in saliva at pre-rinse, 1 h post-rinse, and 4 h post-rinse
2. Proportion of salivary Tannerella forsythia and Treponema denticola at 1 h and 4 h post-rinse relative to pre-rinse
3. Proportion of Tannerella forsythia and Treponema denticola relative to total salivary bacteria at pre-rinse, 1 h post-rinse, and 4 h post-rinse
4. Concentrations of breath volatile sulfur compounds (hydrogen sulfide, methyl mercaptan, and dimethyl sulfide) at pre-rinse, 1 h post-rinse, and 4 h post-rinse
5. Proportion of salivary Streptococcus mutans and Streptococcus sobrinus at 1 h and 4 h post-rinse relative to pre-rinse
6. Proportion of Streptococcus mutans and Streptococcus sobrinus relative to total salivary bacteria at pre-rinse, 1 h post-rinse, and 4 h post-rinse
7. Proportion of Streptococcus mutans and Streptococcus sobrinus relative to total salivary streptococci at pre-rinse, 1 h post-rinse, and 4 h post-rinse
8. Salivary weight at pre-rinse, 1 h post-rinse, and 4 h post-rinse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single mouth rinse with 20 mL of a 0.1% (w/v) seaweed extract solution
Rinse duration: 1 minute
Interventions/Control_2
Single mouth rinse with 20 mL of water
Rinse duration: 1 minute
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women aged 20 to <65 years at the time of informed consent
2. Participants who tested positive for Porphyromonas gingivalis in the screening test
3. Participants who do not receive regular dental maintenance
4. Participants who do not currently receive treatment for dental caries or periodontal disease and have at least 20 natural teeth
5. Participants who agree not to receive any dental treatment until the end of this study
6. Participants who have received an adequate explanation of the study's purpose and procedures, who have the capacity to provide informed consent, and who voluntarily agree in writing to participate based on a sufficient understanding of the study
Key exclusion criteria
1. Participants judged to have dental caries classified as C3 or more advanced, or to have severe periodontal disease
2. Participants who have serious illnesses, including diabetes, chronic kidney disease, gastrointestinal disorders, pulmonary diseases, or malignant neoplasms, or who are taking medications
3. Participants with noticeable oral lesions or trauma, or those with periodontal or oral conditions requiring immediate treatment
4. Participants who have a smoking habit
5. Participants who are breastfeeding, are currently pregnant, or intend to become pregnant during this study period
6. Participants who have used antibiotics or antimicrobial agents within one month prior to the screening test
7. Participants who use mouthwashes similar to this study product, or who use dentist-dispensed toothpaste, mouthwash, or other oral care products that may affect this study's outcomes
8. Participants who are unable to refrain from using medications that may influence oral hygiene or from using or consuming supplements or health foods during this study period
9. Participants who are at risk of developing allergic reactions to food
10. Participants who use orthodontic appliances or wear removable dentures
11. Participants suspected of having oral dryness (saliva flow: less than 3 mL/5 min)
12. Participants with a salivary pH of <=6.2
13. Participants who have participated in another study, including those involving oral care products, within one month prior to the start of this study, or who intend to participate in another study during the study period
14. Participants who report, or are diagnosed by a dentist with, conditions that may affect oral malodor
15. Participants who are judged by the principal investigator to be unsuitable for participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Yanagisawa |
Organization
Yanagisawa Dental Office
Division name
Director
Zip code
174-0022
Address
8th Floor, Mishina Building, 1-18-1 Minamiikebukuro, Toshima, Tokyo, Japan
TEL
03-3982-4790
varitudo@kpe.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Ryoya |
| Middle name | |
| Last name | Kambara |
Organization
Riken Vitamin Co,,Ltd.
Division name
Healthcare Unit
Zip code
174-0065
Address
1-15-10 Wakagi, Itabashi, Tokyo, Japan
TEL
03-3933-4148
Homepage URL
ryo_kanbara@rike-vita.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin Co,,Ltd.
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 of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gumma
Tel
027-212-5608
sagawa@mc-connect.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 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 24 | 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 | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069629
