Pilot Efficacy Study to Treat Gingivitis

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biomedical Development Corporation
• Collaborator: National Institute of Nursing Research (NINR)

Criteria

Inclusion Criteria:

Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study:

• Males or non-pregnant females of 18 years of age, and in good general health, as determined by Investigator.

• Have 16 natural, gradable teeth and good dental health, as determined by Investigator.

• Have > 25% sites with GI scores > 2.

• Have average PI score > 2.

• Use of effective method of contraception for the duration of the study or permanently sterilized.

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

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

Subjects meeting any of the following exclusion criteria are not eligible for participation in this study:

• 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.

• Treatment with antibiotic within the one (1) month period prior to the screening examination.

• Presence of heart murmur, history of rheumatic fever, valvular disease or prosthetic implant requiring antibiotic premedication.

• History of thyroid disease.

• Known sensitivity or allergy to iodine.

• Known sensitivity or allergy to shellfish.

• History of diabetes.

• History of autoimmune disease.

• 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 influence the outcome of the study.

• Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores.

• Presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed.

• History of early onset periodontal disease or acute necrotizing ulcerative gingivitis.

• History of or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study.

• History of, or current drug abuse.

• 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).

• Concomitant therapy with another investigational drug or device without prior approval from the Sponsor within four (4) weeks prior to Visit 2 (Study Day 1).

• Concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months.

• Females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study.

• Unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment (drug), and to return for follow-up visits as required by the protocol.