Healthy male/female volunteers
Conditions
Interventions
Continuous application of the liquid toothpaste to the volunteers every daily meal for 4 weeks.
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 three months to the current trial. (6) Volunteers 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 this study. (4) Volunteers with toothbrushing not less than four times a day, including the brushing before and after breakfast, before their normal bedtime,etc. (5) Pregnant, possibly pregnant, or lactating women, during this clinical study. (6) Volunteers who are now under other clinical studies with some kind of medicine/food, or willing to participate in similar tests. (7) Volunteers having their stimulating saliva with no more than 3.0 mL for 5 min. (8) Volunteers having stimulating saliva with no more than a pH of 6.2. (9) Volunteers with some kind of allergy. (10) Volunteers equipped with removable denture, and/or dental implant on the dental object. (11) Volunteers straitening their teeth. (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) 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. Existence quantification of P. gingivalis / T. forsythia in saliva 4. Free Hb level / LDH activity in saliva 5. Overall effectiveness 6. Concentrations of volatile sulfur compounds, just like H2S, Me3SH and (CH3)2S 7. IL-1beta / IL-8 activity in saliva | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed