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Sponsors and Collaborators: |
Biomedical Development Corporation National Institute of Nursing Research (NINR) |
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Information provided by: | Biomedical Development Corporation |
ClinicalTrials.gov Identifier: | NCT00391547 |
The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.
Condition | Intervention | Phase |
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Gingival Diseases |
Drug: Frio Oral Rinse |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Pilot Efficacy Study to Treat Gingivitis |
Estimated Enrollment: | 14 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2007 |
Gingivitis is an endemic disease that is a precursor to periodontal disease. Two mouthrinse agents, Peridex and Listerine, have received the Seal of Acceptance from the Council on Dental Therapeutics of the American Dental Association for the control of supragingival plaque and gingivitis. Peridex (0.12% chlorhexidine, bisbiguanide cationic detergent) is a prescription mouthrinse that demonstrates potent anti-plaque and anti-gingivitis action. Chlorhexidine rinses are also prescribed to prevent post surgical infections. Chlorhexidine has broad spectrum antibacterial activity and substantivity. With prolonged use, chlorhexidine maintains its effectiveness but causes staining of natural teeth and composite materials used in restorative dentistry. Other side effects associated with chlorhexidine are calculus formation and possible alterations in taste. Although chlorhexidine rinses and supragingival irrigations have demonstrated significant efficacy in reducing plaque and gingivitis, chlorhexidine has had a minimal impact in treating periodontal disease. Listerine, comprised of essential oils, is an over-the-counter mouthrinse that is less effective than chlorhexidine in controlling plaque and gingivitis, but has minimal side effects. Other agents such as quaternary ammonium compounds and metal salts are rarely used alone but can be used in combination with other antimicrobial rinses to enhance their effectiveness.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study:
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:
United States, Missouri | |
University of Missouri at Kansas City, School of Dentistry | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Lynn Friesen, DDS | University of Missouri at Kansas City, School of Dentistry |
Study ID Numbers: | 0609059R44NR009015-02, NIH Grant No. 9R44NR009015-02 |
Study First Received: | October 20, 2006 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00391547 |
Health Authority: | United States: Food and Drug Administration |
Gingivitis Disease |
Mouth Diseases Periodontal Diseases Gingival Diseases Gingivitis Stomatognathic Diseases |