Healthy Japanese subjects
Conditions
Interventions
Take the test food one tablet a day before bedtime for six weeks
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Yuseikai, Horiuchi Dental Clinic Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged to be eligible to participate in the study by the physician 3. Subjects who has a high measured value of P. gingivalis at screening (before consumption) 4. Subjects who has a high measured value of GI at screening (before consumption)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values and logarithmic values of Porphyromonas gingivalis (P. gingivalis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed