Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis
Condition: Periodontal Disease
MeSH terms: Periodontitis; Periodontal Diseases
Intervention: ST266; Saline (0.9% NaCl)
Intervention description: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).; Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an
      adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed, written informed consent prior to participation in any
             study-related procedures.

          -  Good general health as evidenced by medical history.

          -  Between 18 and 85 years of age at time of informed consent signature.

          -  Male or female.

          -  Minimum of 18 teeth, excluding third molars.

          -  Having moderate to severe periodontal disease according to AAP definition (at least 6
             teeth ≥6 mm PD and ≥3 mm CAL at baseline).

          -  Having >30 percent bleeding sites upon probing.

          -  Willing to abstain from chewing gums and other mouth rinses for the study duration.

          -  Ability and willingness to attend all study visits and comply with all study visits
             and comply with all study procedures and requirements.

          -  Willingness to abstain from routine dental care.

          -  For women with reproductive potential, willingness to use highly effective
             contraception (e.g. licensed hormonal contraception, intrauterine device, abstinence,
             or vasectomy in partner).

        Exclusion Criteria:

          -  Presence of orthodontic appliances.

          -  A soft or hard tissue tumor of the oral cavity.

          -  Any dental condition that requires immediate treatment, such as carious lesions.

          -  Participation in any other clinical study within 30 days of screening or during the
             study.

          -  Pregnancy or lactation. If a subject meets this criterion, she may be rescreened for
             study participation when she no longer meets this criterion.

          -  Antibiotic therapy within the last 30 days.

          -  Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti
             inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily) is allowed.

          -  Immunocompromised subjects.

          -  Subjects with cancer or a history of cancer within the last 5 years of screening.

          -  Any medical history or any concomitant medication that might affect the assessment of
             the study treatment or periodontal tissues, such as diabetes, nifedipine, phenytoin
             (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.).

          -  Involvement in the planning or conduct of the study.

          -  History of any clinically significant disease or disorder which, in the opinion of the
             investigator, may either put the subject at risk because of participation in the
             study, or interfere with interpretation of the subject's study results.

          -  Previous randomization for treatment in the present study