Exploratory Study of Iocide Oral Rinse in a Diabetic Population

Exclusion Criteria

• •1. History, or current evidence, of any significant acute or chronic medical or psychiatric condition that, in the opinion of the Investigator, would render examination difficult or invalid or prevent the subject from active study participation
• •2. TPOab positive
• •3. Baseline serum level of TSH \<0.35 or \>5.5
• •4. Treatment with antibiotic within the three (3) month period prior to the screening examination
• •5. Presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
• •6. History of thyroid disease
• •7. Purported sensitivity or allergy to iodine
• •8. Known sensitivity or allergy to shellfish
• •9. History of autoimmune disease, or chronic infections such as HIV or hepatitis
• •10. History of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
• •11. History of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
• •12. Gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the Investigator, could alter the treatment needs during the study
• •13. Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores
• •14. Presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed
• •15. History of or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study
• •16. History of, or current drug abuse
• •17. Use of concomitant medication that, in the opinion of the Investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin)
• •18. Concomitant therapy with another investigational drug or device without prior approval from the Sponsor within four weeks prior to Visit 2 (Study Day 1)
• •19. Concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months
• •20. Females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study
• •21. Residence in the same household as a subject already enrolled in the study (inclusion may create blinding and/or compliance issues)
• •22. Unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment, and to return for follow-up visits as required by the protocol.