Professional Use

Instructions for use

Safety data sheet

Clinical Examples

A Moderately Large Aphthous Ulcer before treatment with DEBACTEROL® Note the typical features – the shallow crater, the ulcer rim and the erythematous ring around the ulcer. At this point the ulcer site is extremely painful.
Immediately Post-Treatment with DEBACTEROL® Note the white membraneous layer of denatured tissue that forms over the the ulcer site after treatment. The DEBACTEROL® is spread across the ulcer bed, over the ulcer rim and extended to cover the erythematous ring. At this point the ulcer site is pain-free and remains pain-free as the ulcer heals.
Two Days Post-Treatment with DEBACTEROL® The white membrane has sloughed from the surface of the ulcer and an opalescent layer now covers the site.
Five Days Post-Treatment with DEBACTEROL® There has been extensive healing with filling of the ulcer bed and marked re-epithelialization. The site of the ulcer is almost grossly undetetctable.

Large Aphthous Ulcer Before Treatment with DEBACTEROL® All of the classical features of aphthous stomatitis are present, including significant pain.
Immediately Post-Treatment with DEBACTEROL® The white Membrane of DEBACTEROL®-precipitated tissue is present, extending over the entire site up to the normal mucosa. This lesion is now pain-free.
Two Days Post Treatment with DEBACTEROL® The white membrane has sloughed from the lesion and an opalescent protective layer remains.
Five Days Post Treatment with DEBACTEROL® Extensive ulcer filling and re-epithelialization are readily apparent.

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.

Clinical Research

Since 1996 Clinical Trials of DEBACTEROL^® have been conducted by Dr. Nelson Rhodus, DMD MPH, Director of Oral Medicine/Diagnosis, University of Minnesota, School of Dentistry. Studies comparing the effectiveness of DEBACTEROL^® with the effectiveness of Kenalog in Orabase^® in the treatment of Recurrent Aphthous Stomatitis have been done and results have been published. 

Additional studies are underway to evaluate the histology of oral mucosa that has been treated repeatedly with DEBACTEROL®.

Research Item	Description
DEBACTEROL® vs. Kenalog Poster Presentation	Composite data inclusive to 12/97 from ongoing clinical trials
DEBACTEROL® vs. Kenalog 1997 IADR Abstract	Clinical trial data to 11/96
Evaluation of DEBACTEROL® for the treatment of Recurrent Aphthous Stomatitis	Published journal article from Quintessence International, 1998