Healthy male/female volunteers
Conditions
Interventions
Gargle with the test product 3 times a day, after each meal (after oral care)
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese men and women between the ages of 20 and less than 65 years old (2) Those who eat three meals a day regularly (3) Those who have at least 4 of the following 6 teeth measurable on the labial and buccal sides: 16 (maxillary right first molar, FDI tooth code; same below), 12 (maxillary right lateral incisor), 24 (maxillary left first premolar), 36 (mandibular left first molar), 32 (mandibular left lateral incisor) and 44 (mandibular right first premolar).Or those who have FDI tooth codes 17, 15, 11, 25, 37, 35, 31, and 45 as substitutes for the aforementioned 6 representative teeth. (4)Those who are not currently undergoing treatment for dental caries and periodontal disease and have at least 20 teeth. (5) Those who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a good understanding of the purpose and content of the study, and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: (1)Those who are determined to have caries (C3 or higher) or severe periodontal disease at the time of screening examination. (2) Those suffering from diabetes mellitus, chronic kidney disease, gastrointestinal disease, lung disease, malignant tumor, etc. and taking medication (3) Those whose stimulated saliva volume for 5 minutes is less than 3.0 mL (4) Those whose pH of stimulated saliva is less than 6.2 (5) Those who have ever been aware of food allergy (6) Those who wear removable dentures. (7)Those who have been diagnosed with dry mouth. (8)Those who are undergoing orthodontic treatment. (9) Those who regularly use water with a functional description. (10)Those who are taking antibiotics or antibacterial agents or have taken them within 1 month of screening test (11) Those who suffer from hay fever or allergic rhinitis and plan to take medications during the study period (excluding eye drops). (12)Smokers (13) Those who are pregnant, intend to become pregnant during the study period, or are breastfeeding. (14) Those who are determined to be unsuitable as research subjects based on the results of tests performed during the screening test. (15) those with a history or current medical history of drug or alcohol dependence (16)Those who are currently participating in research involving the use of other foods or drugs, or the application of cosmetics or medicines, or those who have participated or intend to participate in other clinical research within one month of obtaining consent. (17)Other persons who are deemed inappropriate as research subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. interview 2. height 3. Weight (BMI) 4. blood pressure and pulse rate 5. hematology: white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, leukocytogram 6. biochemical tests: total protein, albumin, AST, ALT, LD (IFCC), total bilirubin, ALP (IFCC), gamma-GT, urea nitrogen (UN), creatinine, uric acid (UA), sodium (Na), chlor (Cl), potassium (K), calcium (Ca), total cholesterol, LDL-cholesterol, HDL-cholesterol, TG (triglycerides), glucose, HbA1c (NGSP) 7. Urinalysis: protein, sugar, urobilinogen, bilirubin, pH, specific gravity, urinary ketones, occult blood reaction 8. dental formula 9. gingivitis index (GI: Lee & Sillness, 1963) 10. dental plaque index (PlI: Silness & Loe, 1964) 11. oral mucosa 12. tooth coloration 13. Tongue Coating Index (photographic) 14. stimulated saliva volume/stimulated saliva pH 15. number of periodontopathogenic bacteria (A.actinomycetemcomitans, P.gingivalis, P.intermedia, T.forsythensis, T.denticola, F.nucleatum) 16. comprehensive analysis of flora in saliva (occupancy and diversity of each species by next generation sequencing) 17. caries-associated bacteria count (total strep, S. mutans, lactobacilli) 18. halitosis measurement (oral chroma: hydrogen sulfide, methyl mercaptan, dimethyl sulfide) 19. subjective and objective symptoms 20. adverse events | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed