Healthy individuals
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy individuals who meet all of the following criteria are included in this study; <Inclusion criteria for provisional registration> 1. Male or female aged 30 year or older and 65 year or younger 2. Individuals who generally take meals three times per day 3. Individuals in whom labial and buccal surfaces of at least 4 teeth among the following teeth are measurable; FDI tooth number 16 (maxillary right first molar, 21 (maxillary left central incisor), 36 (mandibular left first molar), 41 (mandibular right central incisor), 44 (mandibular right first premolar) or healthy individuals who have the following teeth in place of the 6 teeth mentioned above; FDI tooth number 17, 15, 11, 22, 25, 37, 35, 31, 42, 45 4. Individuals with 20 teeth or more 5. Individuals without habit of polishing tongue at teeth brushing 6. Individuals who provide their consent to participate in this study in written form after full explanation of this study <Inclusion criteria for actual registration> 7. Individuals in whom P. gingivalis is detected at the screening test
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study; 1. Individuals with smoking habit 2. Individuals who are taking medical agents due to diabetes mellitus, chronic renal disease, gastrointestinal disorder, pulmonary disease, malignant tumor, etc. 3. Individuals who routinely use products that inhibit periodontopathogenic bacteria, such as mouth wash agents 4. Individuals whose stimulant saliva is 3.0mL or less
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount and change of periodontopathogenic bacteria (P. gingivalis and F. nucleatum bacteria) in stimulated saliva measured by PCR invader method | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement at each observation point and change from baseline to each observation point of following items; 1. Amount of periodontopathogenic bacteria (P. gingivalis and F. nucleatum bacteria) in stimulated saliva measured by PMA-qPCR method 2. Amount of other bacteria (Campylobacter concisus) in stimulated saliva 3. Characteristics of stimulated saliva (pH, amount) 4. Concentration of calprotectin in stimulated saliva 5. Concentration of vascular endothelial growth factor (VEGF) and human epidermal growth factor (hEGF) in stimulated saliva 6. clinical indicators (gingival index (GI), plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinincal attachment level (CAL), and tongue coating score) | — |
Countries
Japan
Contacts
Soiken, Inc. Clinical Study Support Division