Study to confirm the effect of functional water in improving oral environment -Placebo-controlled, randomized, double-blind, parallel-group comparison
- Conditions
- Healthy male/female volunteers
- Registration Number
- JPRN-UMIN000054007
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method