Healthy male/female adults
Conditions
Interventions
Mouthwash using the test liquid (10 mL) for 20 sec, without rinsing.
Mouthwash using the placebo liquid (10 mL) for 20 sec, without rinsing.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females ranging in age from 20 to 64, at the time of informed consent. (2) Subjects being applicable to at least one of the following criteria: Subjects with self-recognition of bad breath Subjects who have been pointed out their bad breath Subjects who are aware of dry mouth (3) Subjects with not less than 112 ppb of hydrogen-sulfide concentration in their breath. (4) Subjects who have received enough explanation about this study and were able to understand that, and to give written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects who are continuously taking medicines that may affect the test results, except applying a nasal spray and eye drops. (2) Subjects who have any spots with not less than 7 mm of probing pocket depth. (3) Subjects who are undergoing dental treatment for tooth decay, gingivitis, etc., or ones having tooth decay. (4) Subjects equipped with partial/full dentures. (5) Subjects being in the process of straightening their teeth. (6) Subjects who have any tooth defecting, or coming off. (7) Subjects having a severe medical history of dry mouth symptom, Sjogren's syndrome, or systemic illness. (8) Subjects who have previous and/or current medical history of serious diseases (e.g., heart, liver, kidney, digestive organ). (9) Females who are pregnant, lactating, or possibly pregnant. (10) Subjects who are taking medicine, foods with functional claims, health foods, and oral care products (mouthwash, etc.) that may affect the improvement of oral function. (11) Subjects with an extremely irregular dietary habits or lifestyle (e.g. alternative work schedule, graveyard shift). (12) Subjects who take excessive alcohol. (13) Subjects who are allergic to drugs or foods. (14) Subjects who are participating or have been participated to the other clinical tests with some kind of medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent. (15) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of hydrogen sulfide | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of bacteria in saliva 2. Autoinducer-2 activity 3. Concentration of methyl mercaptan 4. Concentration of dimethyl sulfide | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Fujimoto
CPCC Company Limited Clinical Planning Department
Outcome results
None listed