Healthy male adults
Conditions
Interventions
Continuous application of the toothpaste to the subjects, three times a day (after every meal) for 4 weeks.
Continuous application of the mouth-wash solution to the subjects, three times a day (after
Sponsors
KSO Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy male subjects ranging in age from 20 to 49 years old. (2) Subjects equipped with not less than 20 teeth, and without some kind of periodontal disease. (3) Subjects having mild-to-moderate gingivitis. (4) Subjects with bad breath at steady state. (5) Subjects having meals three times a day, and toothbrushing after each meal. (6) Subjects having not less than four teeth among measurable six teeth (FDI: 16, 21, 24, 36, 41, 44), or their alternatives (FDI: 17, 15, 11, 22, 25, 37, 35, 31, 42, 45). (7) Subjects who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) At the screening test, subjects who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease. (2) Subjects with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases. (3) Subjects having need of some kind of scaling with oral surgery treatment and/or anesthesia. (4) Subjects with some kind of allergy. (5) Subjects equipped with removable denture. (6) Subjects with smoking habit. (7) Subjects who are now under the other clinical trials with some kind of medicine/food, or going to take part in those trials. (8) Subjects who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test. (9) All through this trial, subjects who have any difficulty in refraining from using some kind of mouth-rinse solution and/or interdental brush. (10) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentrations of volatile sulfur compounds, such as H2S, Me3SH and Me2S | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gingivitis index 2. Swelling 3. Reddening 4. Overall effectiveness 5. Tongue coating | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed