NCT00391547

Pilot Efficacy Study to Treat Gingivitis

Phase II Pilot Efficacy Study to Treat Gingivitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (planned)
• Sponsor: Biomedical Development Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Gingival Diseases

Interventions

Type	Name	Description
DRUG	Frio Oral Rinse

Timeline

• Start date: 2006-10-01
• Completion: 2007-01-01
• First posted: 2006-10-24
• Last updated: 2007-10-22

Locations

1 site across 1 country: United States