Dental Caries Clinical Trial
Official title:
A Phase 2, Double-Blind, Placebo-Controlled and Open-Label Multi-Center Study to Evaluate the Microbiology and Safety of C16G2 Administered in Multiple Oral Gel Doses to Adult and Adolescent Dental Subjects
The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of time either with a toothbrush or a custom dental tray can effectively kill bacteria in the mouth that cause dental cavities.
This multi-center, multiple-arm study will evaluate the microbiological activity and safety
of C16G2 Gel in male and female dental subjects, 12 to 75 years of age. The study will be
conducted in a randomized, double-blind, placebo-controlled and open-label manner and enroll
adolescent (12-17 years of age) and adult subjects (18-75 years of age).
A total of approximately 128 study subjects will be enrolled into up to 7 study arms. Study
drug (C16G2 Gel or Placebo) will be administered via manual brush gel application (MBGA) or
tray gel application (TGA). Two C16G2 concentrations will be evaluated. Four study arms will
be conducted in a double blind manner, with a treatment allocation ratio of 4:1
(C16G2:Placebo), three study arms will be conducted in an open-label manner. Before dosing,
eligible subjects will undergo professional dental prophylaxis on Day 0. Clinic visits for
all study arms will include Visit 1 (Screening/Days -21 to 0), and a varying number of dosing
and follow-up visits.
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