Effects of consumption of the test food on the oral environment in healthy subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000045810
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Not provided
Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. currently 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. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. are currently taking medications (including herbal medicines) and supplements 6. have used antibiotics within the preceding three months before the agreement to participate in this trial 7. are allergic to medicines and/or food 8. regularly use gargle medicine 9. use artificial tooth, post crowns, dentures, implants or bridges 10. use floss, interdental brushes, and mouthwash at brushing their teeth 11. have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months before the agreement to participate in this trial 12. are being treated, have a past medical history, or are suspected of having Sjogren's syndrome 13. suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease 14. are being treated periodontosis or dental caries 15. are being treated or are diagnosed with any of dental diseases 16. are smokers, or started smoking cessation within one year before the agreement to participate in this trial 17. are pregnant, breast-feeding, and planning to become pregnant 18. suffer from COVID-19 19. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 20. are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The gingival index (GI)
- Secondary Outcome Measures
Name Time Method 1. The number of periodontosis-related bacteria 2. The evaluation of periodontosis 3. The number of dental caries-related bacteria 4. Halitosis 5. Questionnaire