Effects of 2-DeNT Oral Topical Powder on Recurrent Aphthous Ulcers

Objective: Recurrent aphthous stomatitis, also known as: RAS, aphthous ulcers, canker sores, are inflammatory ulcers of the oral mucosa resulting in the breakdown and loss of surface epithelium.  There are three presentations:  minor, major and herpetiform RAS.  All are recurring painful ulcers of the mucosa that normally occur on movable/ non-keratinized mucosa.  RAS is the most common inflammatory ulcerative condition of the oral cavity in North America.  It continues to be a problem to those affected and practitioners alike because there is no clear etiology. Although a wide range of treatment modalities have been tried, they have only shown variable success.  The purpose of this study is to compare the 2-DeNT oral topical powder with a placebo to evaluate differences in healing times and pain levels.  Methods:  A power analysis determined that 34 subjects would be needed in this study.   The study was designed to be a double blind, randomized, prospective study with a crossover design– meaning that each patient would need to use both the experimental and placebo powder.  The components of the experimental powder are: dexamethasone, diphenhydramine, tetracycline, metronidazol, nystatin zinc oxide and karaya gum.  The placebo powder contained zinc oxide and karaya gum.  Additionally, yellow dye was added to imitate the color of the original powder.  Subjects were asked to complete a daily log that measured the size of the ulcer, the degree of redness, and the level of pain or discomfort using a visual analogue scale.  Results: The experimental group shows a 50% greater decrease in size by day 5, which is significant at the .001 level.  There were similar findings for decreases in pain and erythema.  Conclusion: When compared to the placebo, the experimental powder (2 DeNT) showed a significantly faster reduction in the size and redness of the ulcer as well as pain from the ulcer.