Pilot Efficacy Study to Treat Gingivitis
The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Phase II Pilot Efficacy Study to Treat Gingivitis|
- Reduction of the Gingival Index values over a 12 weeks period.
- Reduction of the Plaque Index values over a 12 weeks period.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391547
|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|