A validation study of changes in salivary volume by one-time using an oral massaging device
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000046540
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method