FDA approves new Decapinol Oral Rinse to help treat gingivitis
ROCKVILLE, MD., April 18, 2005 -- The FDA has approved a new prescription treatment for gingivitis, a common gum disease that affects most adults at some point in their lives. Decapinol Oral Rinse treats gingivitis by reducing the number of bacteria that attach to tooth surfaces and cause dental plaque. Decapinol is approved for use in persons 12 years of age or older when routine oral hygiene is not adequate to prevent gingivitis. Decapinol is not recommended for use by pregnant women.
"This new dental rinse helps treat gingivitis when tooth brushing and flossing are not enough," said Dr. Daniel Schultz, Director of FDA's Center for Devices and Radiological Health. "This product can lead to a substantial reduction in gingivitis."
Gingivitis is an inflammation of the gums that often appears as swollen, red, or bleeding gums. Scientists believe plaque-forming bacteria that live in the mouth and on tooth surfaces are a cause of gingivitis. Substances released by the bacteria cause the gum inflammation. Reduction of plaque bacteria can decrease the inflammatory substances and cause a reduction in gingivitis.
Clinical studies were conducted in adults with mild to severe gingivitis. In these studies, Decapinol was compared either to "no treatment" or to an antimicrobial rinse. The studies showed that Decapinol decreases gingivitis up to 60% -- compared to no treatment and when used as instructed with recommended brushing and flossing.
Decapinol Oral Rinse is being regulated as a medical device and not as a drug because its primary mode of action is to create a physical barrier, rather than to act chemically. Decapinol contains a substance called a surfactant that acts as a physical barrier, making it harder for bacteria to stick to tooth surfaces. FDA also has approved a number of other anti-gingivitis oral rinses, but since these products act chemically to kill bacteria that live in the mouth, they are regulated as antimicrobial drugs rather than as devices.
Decapinol Oral Rinse is manufactured by Sinclair Pharmaceuticals Limited, based in the United Kingdom.
Posted: April 2005