Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects

Inclusion Criteria

• •1. Males and females, 12-75 years of age, inclusive, at the time the Assent and/or Informed Consent Form is signed
• •2. Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun \>30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
• •3. Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
• •4. Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the Medical Monitor on a case-by-case basis.
• •5. Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns, sealants
• •6. Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
• •7. Have a salivary S. mutans of 1.0 x 10\^5 colony forming units (CFUs)/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
• •8. Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
• •9. Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
• •10. Willing and able to comply with oral hygiene and diet instructions
• •11. Has dentition adequate for custom dental tray gel application
• •12. Able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures
• •13. Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times