Healthy male/female volunteers
Conditions
Interventions
Continuous application of the toothpaste to the subjects, three times a day (after every meal) for 4 weeks.
Continuous application of both the toothpaste and the solution to the subjects, three times
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female volunteers ranging in age from 35 to 64 years old. (2) Volunteers having mild-to-moderate gingivitis. (3) According to the clinical observation, volunteers having not less than one periodontal pocket with not less than 4 mm. (4) At the screening test, volunteers who were determined as a patient having not less than one tooth equipped with level-1 or 2 on the GI index. (5) Volunteers having no scaling about the observation region within the last one month to the current study. (6) Volunteers usually having meals three times a day, and toothbrushing after each meal. (7) Volunteers having not less than four teeth among measurable six ones (FDI: 16, 12, 24, 36, 32, 44), or their alternatives (FDI: 17, 15, 11, 25, 37, 35, 31, 45). (8) Volunteers equipped with not less than 20 teeth, and without some kind of periodontal disease. (9) Volunteers who gave informed consent to take part in this study after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) At the screening test, volunteers who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease. (2) Volunteers with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases. (3) Volunteers having some kind of systemic disease, which has serious difficulty in participating in this study. (4) Volunteers with toothbrushing not less than four times a day. (5) Volunteers cannot stop taking or using medicines that may affect oral health during the study period. (6) Pregnant, possibly pregnant, or lactating women, during this clinical study. (7) Volunteers having their stimulating saliva with no more than 3.0 mL for 5 min and having been diagnosed with dry mouth. (8) Volunteers having stimulating saliva with no more than a pH of 6.2. (9) Volunteers having experience of allergies to the components of research products, metals, or medicines. (10) Volunteers equipped with removable denture, and/or dental implant on the dental object. (12) Volunteers falling into the habit of smoking. (13) Volunteers who have regularly used some kind of health food. (14) Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly o r within the last month to the screening test. (15) Volunteers currently participating in or willing to participate in research on other pharmaceuticals or foods, or research on applying cosmetics or drugs (16) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gingivitis index 2. Dental plaque index 3. Depth of periodontal pocket 4. Bleeding on Probing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Swelling 2. Reddening 3. Overall effectiveness 4. Free Hb value / LDH activity in saliva 5. IL-1beta / IL-8 activity in saliva 6. Existence quantification of P.gingivalis/T.forsythensis/T.denticola/F.nucleatum in saliva 7. Tongue coating 8. Concentrations of volatile sulfur compounds, just like H2S and CH3SH and (CH3)2S | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed