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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Texas A&M University

Current Primary Outcome: Ulcer size [ Time Frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days ]

Size was measured from the outside edge of the white border to the outside edge of the opposite white border. If the ulcer was oval in shape, its longest dimension was measured.


Original Primary Outcome: Same as current

Current Secondary Outcome: Erythema [ Time Frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days ]

Erythema levels were recorded on a scale of 0 to 4 (0= no redness, 1= faint redness, 2= light red/pink, 3= moderate redness, 4= severe redness) using a guide that provided both picture and word descriptions of the degree of redness associated with each number on the scale


Original Secondary Outcome: Same as current

Information By: Texas A&M University

Dates:
Date Received: April 24, 2014
Date Started: March 2012
Date Completion:
Last Updated: June 4, 2014
Last Verified: June 2014