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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mouth Rinse Administration | Other | Day 0, three consecutive C16G2 or placebo rinse administrations followed by three single C16G2 or placebo rinse administrations. Days 1 to 6 two additional C16G2 or placebo rinse administrations. |
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| Dental Tray Gel Administration | Other | Day 0, two C16G2 or placebo gel dental tray applications and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo dental tray applications and two C16G2 or placebo rinse administrations. |
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| Electric Toothbrush Gel Application | Other | Day 0, four C16G2 or placebo gel administrations applied with an electric toothbrush and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo gel administrations applied with a electric toothbrush and two C16G2 or placebo rinse administrations. |
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| Manual Toothbrush Gel Application | Other | Day 0, four C16G2 or Placebo gel administrations applied with a manual toothbrush and four C16G2 or Placebo rinse administrations. Days 1 to 6, two C16G2 or Placebo gel administrations applied with a electric toothbrush and two C16G2 or Placebo rinse administrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C16G2 Rinse | Drug | Active rinses are 1.6 mg/mL C16G2. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening, Baseline, Days 1-7, & Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening, Baseline, Days 1, 7 & 14 |
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Inclusion Criteria:
Subjects are eligible to participate if they meet the following criteria:
Exclusion Criteria:
Subjects are excluded from participation if any of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Marberger, DDS | Jean Brown Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plaza West II Dental Group | Kalispell | Montana | 59901 | United States | ||
| Jean Brown Research |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Drug | Placebo is the vehicle without C16G2 |
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| C16G2 Gel | Drug | Active C16G2 Gel is 3.2 mg/mL |
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| 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). | Screening, Baseline, Days 1, 7 & 14 |
| Salt Lake City |
| Utah |
| 84124 |
| United States |