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Information
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FOR IMMEDIATE RELEASE
April 18, 2005
FDA Approves New Oral Rinse to Help Treat Gingivitis
The Food and Drug Administration (FDA) today approved a new
prescription treatment for gingivitis, a common gum disease
that affects most adults at some point in their lives. The
Decapinol Oral Rinse treats gngivitis 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 oarl higiene 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
gingivitsi. 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
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.
http://www.fda.gov/bbs/topics/news/2005/NEW01174.html
888-INFO-FDA
ingivitis, gingvitis, ginivitis, gingivtis, gingivitsi, gignivitis
Gingivitis
is a form of periodontal disease. Periodontal disease is when
inflammation and infection destroy the tissues that support
the teeth, including the gingiva (gums), the periodontal ligaments,
and the tooth sockets. Gingvitis is caused by the long-term
effects of plaque deposits. Plaque is a sticky material that
develops on the exposed portions of the teeth, consisting
of bacteria, mucus, and food debris. It is a major cause of
tooth decay. Unremoved plaque mineralizes into a hard deposit
called tartar that becomes trapped at the base of the tooth.
Plaque and tartar irritate and inflame the gingiva. Bacteria,
and the toxins bacteria produce, cause the gums to become
infected, swollen, and tender.
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