Effects of consumption of the test food on the oral cavity environment in healthy subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000041863
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 14
Not provided
Subjects who 1.undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. currently taking medicines (include herbal medicines) and supplements 6. have used antibacterial drugs within the last three months before the agreement to participate in this trial 7. allergic to medications and/or the test-food-related products 8. regularly use gargle medicine 9. use artificial tooth, post crowns, dentures, or implants 10. regularly use floss, interdental cleaner, and mouthwash 11. have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months 12. have a medical history, current illness, or are suspected to be a Sjogren's syndrome 13. have disorders associated with salivary gland such as dry mouse and salivary stone disease 14. undergoing medical treatment of periodontal disease or dental caries 15. are under treatment or diagnosed with any of dental diseases 16. are smokers, or started smoking cessation within a year before the invitation to participate in this trial 17. are lactating, pregnant, or intending to become pregnant 18. have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial 19. are judged by the principal investigator as ineligible to participate in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The measured values and logarithmic values of Porphyromonas gingivalis (P. gingivalis)
- Secondary Outcome Measures
Name Time Method 1. The questionnaires (Likert Scale method) 2. Gingival Index (GI), Plaque Index (PlI), bleeding on probing, depth of periodontal pockets, and progression of dental caries