The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to
 evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous
 stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of
 less than 48 hours duration. It was randomly determined which powder was used first; all
 subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder
 twice daily and maintained a daily log recording the size of the ulcer, its erythema score,
 and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer
 was resolved.
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.