None
Conditions
Interventions
Single mouth rinse with 20 mL of a 0.1% (w/v) seaweed extract solution Rinse duration: 1 minute
Single mouth rinse with 20 mL of water Rinse duration: 1 minute
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactRyoya Kambara
Riken Vitamin Co,,Ltd. Healthcare Unit
Outcome results
None listed