The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer

Inclusion criteria

• a history of minor recurrent aphthous stomatitis (RAS) lesions occurring at least 3-4 time/ year, and usually requiring 5 or more days to resolve
• presence of an active ulcer of less than 48 hours duration on either the buccal or labial mucosa (making them more easily accessible for powder application)
• willing and able to give informed consent

Exclusion criteria

• pregnant or lactating
• if ulcers were manifestations of a systemic disease process such as ulcerative colitis, Crohn's disease, Behcet's syndrome, or anemia;
• concurrent clinical conditions that could either pose a health risk to the patient by being involved in the study or potentially influence the outcome of the study
• hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, karaya gum, or zinc oxide
• having used corticosteroids, oral retinoids, or other immunomodulatory agents within one month of participation in the study; non-steroidal anti-inflammatory agents (e.g., aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within one month of participation in the study or any use within five days of participation in the study; topical medication (including steroids, retinoids, and anti-microbial drugs) within two weeks of participation in the study, systemic antibiotics within two weeks of participation in the study; any preparation or medication (OTC or prescription) applied to the ulcer within 48 hours of participation in the study
• history of drug or alcohol abuse
• having had any dental work within 2 weeks of study entry
• having had any orthodontic or oral appliances (that could cause oral trauma) within 1 cm of the ulcer or any recollection of trauma in the area of the ulcer
• participating in any other study involving investigational or marketed products within 1 month of study entry or plans to participate in such an investigation during this study.