Exploratory Study of Iocide Oral Rinse in a Diabetic Population

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biomedical Development Corporation
• Collaborators: Foundation Of Collaborative Unique Science (FOCUS); Methodist Healthcare Ministries of South Texas

Criteria

Inclusion Criteria:

1. Have self-reported type 2 diabetes of more than three months duration.

2. A current HbA1c value between 7.0% and 12%.

3. Report no change in diabetes-related medications during the three months prior to enrollment.

4. Be at least 35 years of age.

5. Have at least 16 natural teeth.

6. Have moderate to severe chronic periodontitis, defined by loss of clinical attachment of >5 mm on two seperate teeth, and no treatment within six months.

7. Able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol

8. Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures

9. Females with childbearing potential must have a negative pregnancy test before and during the study period. Sexually active females must be using an effective form of birth control. These methods include oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.

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.