Healthy male/female adults
Conditions
Interventions
Utilization of the test device to the subjects for 9 min for single use.
Utilization of the placebo device to the subjects for 9 min for single use.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 30 to 79 at the moment of informed consent. (2) Subjects with salivary secretion of not less than 2 g but no more than 6 g, at the moment of preliminary examination. (3) Subjects who can give informed consent to take part in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who take steadily (not less than three times a week) in the health-specific/functional (e.g., reduced coenzyme Q10-containing)/supplementary/ health foods, which might affect the test results. (2) Subjects who have taken affecting medicines (e.g., antihistamine/ antidepressant/antihypertensive), and have any difficulty in refraining from taking them during this study. (3) Subjects who use some kind of imitation of the test device (e.g., an electric toothbrush equipped with supersonic vibration, oral care products) habitually, and have any difficulty in refraining from using them during this study. (4) Subjects who have been to the hospital for dental treatment within three months prior to the consent, or those who are now under the treatment (except taking a periodic dental checkup). (5) Subjects fully realized that their gums are liable to swell up and bleed. (6) Subjects equipped with full dentures, or being in the process of straightening their teeth. (7) Subjects who have previous/current medical history of severe cardiac, hepatic, renal, digestive or oral diseases. (8) Subjects who are now under other clinical tests with some kind of medicine and/or health food, or took part in those within four weeks before this study, or are going to participate in those after giving informed consent to take part in this study. (9) Pregnant, possibly pregnant, and lactating women. (10) Subjects having latex-related allergy. (11) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective questionnaire | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed