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Clinical Indications

DEBACTEROL® has been used for decades in the United States for the treatment of a variety of ulcerating lesions and minor trauma of the oral mucosa. As a semi-viscous liquid, DEBACTEROL® has surface tension properties that enable very small quantities of the material to adhere tightly to the surface of common dental and medical instruments for carefully limited applications. DEBACTEROL® can be applied in larger quantities through the use of cotton swabs dipped in the product. Even larger amounts are commonly layered into necrotic areas using a syringe and blunt needle. The combination of physical characteristics, the dark-brown color and intense denaturant activity allows for very precise treatement of any size or type of lesion in virtually any area of the oral cavity.

By far the most frequent indication for DEBACTEROL® is in the treatment of Recurrent Aphthous Stomatitis (RAS). Aphthous Stomatitis (also known as Aphthous Ulcers, or, Canker Sores) is the most common disorder of the mouth.

In the United States Aphthous Stomatitis has been reported to be found in 15% to 65% of various population subgroups with a prevalence rate of approximately 20% overall. Data published by the WHO and other public health institutions shows that overall prevalence rates in developed countries range from 20 - 25%, but in some heavily populated underdeveloped countries of Asia, Africa and South America, prevalence rates are as high as 50%.

Some of the most difficult mouth ulcers to manage are those that occur in patients with an underlying systemic illness. Many systemic diseases, and their treatments, can severely limit the body's own natural healing capabilities, while the pain of persistent oral ulcers aggravates problems with eating and drinking. For example, frequent RAS-like lesions are a well known complication of AIDS. In addition, oncology patients receiving cytotoxic therapy are also known to develop severe intractable stomatitis as a side effect of their treatment. Patients who are chronically disabled for a variety of reasons, physical and mental, are known to develop ulcerating oral lesions because their disability leads to poor dental health habits.

There are no comprehensive and definitive studies on the prevalence of all of the varieties of ulcerating oral lesions worldwide. However, it is certainly possible to infer from the information found in a number of sample surveys that, at any point in time, from 30% to 40% of the world's population suffers from periodic ulcerating oral lesions of one kind or another.