A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: C16G2 Varnish; Placebo Varnish
Intervention description: Antimicrobial Peptide; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Enrollment: 33.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in
      multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, 12-75 years of age

          2. Adults subjects provide written informed consent and adolescent subjects give written
             or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written
             informed consent

          3. Female subjects of childbearing potential 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 a same sex partner or partner
             who has had a vasectomy at least six (6) months prior to the screening visit

          4. Negative urine pregnancy test in all females of childbearing potential (past menarche)

          5. Male subjects of sexual activity age: 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

          6. 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 (general, 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.

          7. Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT
             having restorations, crowns or sealants

          8. Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes

          9. Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis
             salivarius-bacitracin (MSB) agar plating

         10. Willing to refrain from using non-study dentifrice and other non-study oral care
             products (oral care rinses, fluoride products, etc.) during the study

         11. Willing to postpone elective dental procedures (e.g., dental cleanings) between
             Screening and final post-treatment visit (End of Study or Early Termination)

         12. Willing and able to comply with oral hygiene and diet instructions

         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

        Exclusion Criteria:

          1. Advanced periodontal disease

          2. Active caries lesion(s) within 30 days prior to study drug administration (confirmed
             by comprehensive caries examination including standard radiographs). Subjects
             presenting with insipient, non-cavitated lesion(s) are not excluded.

             Note: If radiographs are deemed appropriate for the study and taken within 6 months
             prior to the Screening visit, these may be used for determining eligibility and not
             required to be repeated at Screening

          3. Partially erupted teeth where the entire crown is not erupted or an operculum is
             present

          4. Medical condition (e.g., artificial heart valve, history of infective endocarditis,
             cardiac transplant with valvular dysfunction, congenital heart disease or total joint
             replacement) for which antibiotics are recommended prior to dental visits and/or
             procedures

          5. Pathologic lesions of the oral cavity (suspicious or confirmed)

          6. Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual
             brackets. Note: Partial dentures, removable retainers and night guards are not
             excluded, provided that they are cleaned regularly throughout the duration of the
             study

          7. Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in
             the opinion of the Investigator could influence the study outcome, beginning 30 days
             prior to Screening until the end of study participation

          8. Medical history indicating the woman is pregnant, breastfeeding/lactating or has a
             positive urine pregnancy test

          9. Participation in a clinical trial or receipt of a non-FDA approved therapy within 30
             days prior to study drug administration (depending on the specifics, participation in
             an observational study is not necessarily excluded)

         10. Presence of any condition or concurrent illness, which in the opinion of the
             Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid
             arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of
             study dentifrice and oral care products, or interfere with the ability to comply with
             study requirements, or jeopardize the safety of the subject or the validity of the
             study results