Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060850) titled 'Evaluation of the effect of a single mouth rinse with a seaweed extract on periodontitis-related bacteria' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - KSO Corporation

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: 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 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 Size - 20

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069629

Disclaimer: Curated by HT Syndication.