Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Active chewable tablet Administration: Examination at the start of the test-food consumption: To suck three tablets without chewing after the examination. Between
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 as healthy and eligible to participate in the study by the physician 3. Subjects who have a relatively large number of periodontosis-related bacteria 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 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 meperidine, hydrocodone, morphine, oxycontin, clonazepam, lorazepam, phenobarbital, or zolpidem 7.have used antibacterial drugs within the last 3 months before the invitation to participate in this trial 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 3 months 12.have a medical history, current illness, or are suspected to be a Sjogren's syndrome 13.suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease 14.whose salivary secretion volume at rest is less than 1.5 g/15 min 15.are under treatment of periodontosis or dental caries 16.undergoing treatment or diagnosed with any of dental diseases 17.are smokers, or started smoking cessation within a year before the invitation to participate in this trial 18.allergic to medications and/or the test food-related products 19.are lactating, pregnant, or intending to become pregnant 20.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial 21.are judged by the principal investigator as ineligible to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of periodontosis-related bacteria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of periodontosis-related bacteria 2. Assessment of periodontosis 3. The number of dental caries-related bacteria 4. Halitosis 5. Oral moisture values 6. The volume of saliva 7. Salivary pH 8. Serum high-sensitivity CRP concentration 9. Salivary IgA 10. Original questionnaires | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed