Healthy Japanese subjects
Conditions
Interventions
Take test food once a day for 4 weeks
Take placebo food once a day for 4 weeks
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Medical Corporation Yuseikai, Horiuchi Dental Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who have P. gingivalis at Scr 7. Subjects who have relatively high GI level at Scr
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The gingival index (GI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of periodontosis-related bacteria 2. The evaluation of periodontosis 3. The number of dental caries-related bacteria 4. Halitosis 5. Questionnaire | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed