Healthy Volunteers
Conditions
Keywords
Pharmacodynamic Study of BCS
Brief summary
To compare pharmacodynamics among the different concentrations of BCS and NS.
Detailed description
2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.
Interventions
To compare pharmacodynamics among the different concentrations of BCS and NS
Sponsors
Lustre Pharmaceutical Lab Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers, males or females. * Females with U-HCG negative. * Signed ICFs, and could conduct this study with investigators.
Exclusion criteria
* History of mouthwash allergies, allergic rhinitis or dermatitis. * Volunteers with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer. * Volunteers with removable denture. * Had received special oral clean.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of aerobic bacterial colonization in oropharyngeal | 24 hours | To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of oral healthy status | 24 hours | To use Plaque Index (PLI) to reflect volunteers' oral healthy status. |
| The volunteers' feelings | 24 hours | The feelings including: comfortable, general comfortable, uncomfortable. |
Countries
China
Outcome results
None listed