Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

Exclusion Criteria

• •History of and/or known risk of life-threatening anaphylactic reactions to taurolidine, any of the components in the investigational drug product.
• •Presence of an acute periodontal abscess.
• •Subjects with healing disorders (e.g. uncontrolled diabetes mellitus, oral cancer) that could compromise wound healing and/or preclude periodontal surgery.
• •Subjects who are taking medications that compromise wound healing presenting with clinical evidence of secondary hyperplastic gingival tissue reactions (e.g. calcium channel blockers or anti-seizure medications)
• •Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
• •Use of systemic antibiotics and, topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) within 45 days prior to Day 1 or expected use during the study trial period.
• •An existing condition that may warrant use of antibiotics during the study trial period.
• •Known Human Immunodeficiency Virus infection or other immunodeficiency syndrome.
• •Subjects with active infectious diseases (e.g. hepatitis, HIV or tuberculosis)
• •Use of agents known to affect periodontal status during the trial and/or use within 45 days prior to Day 1 e.g. immunosuppressants, nasal or oral corticosteroids, calcium channel blockers, phenytoin or anticoagulants.
• •Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day (smokeless nicotine products are NOT excluded)
• •Participation in another clinical study with an investigational agent within 90 days prior to Day 1.
• •Subjects who received oral health treatments/interventions within 90 days of Day 1, which the investigator believes may interfere with the periodontal parameters to be assessed in this study (e.g., significant dental and/or gum/oral tissue work).
• •SRP or periodontal surgery within 12 months prior to Day 1.
• •Subject who have a medical and/or dental condition (e.g. a current clinically unstable occlusal situation) and/or use medications/supplements which the investigator believes makes him/her unsuitable for participation in the study