The focus of the study is to evaluate the safety of multiple study drug administrations and the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will compare a liquid and gel product applied in different modes.
The study will evaluate the safety of multiple study drug administrations as assessed by adverse event monitoring, oral cavity assessments, targeted physical exams and vital signs. The study will also assess the study drug's ability to selectively reduce or eliminate specific bacteria in the mouth by comparing a liquid and gel product applied in different modes, such as mouth rinse administration and gel application using a dental tray, electric toothbrush or manual toothbrush administered over 7 consecutive days. Subjects will be followed for approximately 8 days after the last study drug administration for safety and microbiology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
Active rinses are 1.6 mg/mL C16G2.
Placebo is the vehicle without C16G2
Active C16G2 Gel is 3.2 mg/mL
Plaza West II Dental Group
Kalispell, Montana, United States
Jean Brown Research
Salt Lake City, Utah, United States
To evaluate the safety of multiple C16G2 Gel and/or C16G2 Rinse administrations in healthy adult subjects.
Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams (C16G2 subjects in the four study arms vs. placebo).
Time frame: Screening, Baseline, Days 1-7, & Day 14
To assess the targeted antimicrobial activity of C16G2 gel and rinse applications as measured by a reduction of dental plaque and salivary Streptococcus mutans (S. mutans).
Saliva and dental plaque samples will be assessed at screening and Days 1, 7 and 14 for S. mutans (C16G2 subjects in the four study arms vs. placebo).
Time frame: Screening, Baseline, Days 1, 7 & 14
To assess total bacteria in dental plaque and saliva post-study drug. administration
Total bacteria will be assessed at screening, baseline and Days 1, 7 and 14 (C16G2 subjects in the four study arms vs. placebo).
Time frame: Screening, Baseline, Days 1, 7 & 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.