The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Information source: Texas A&M University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Minor Recurrent Aphthous Stomatitis Lesions
Intervention: 2-DeNT powder (Drug); Placebo Comparator (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: Texas A&M University
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.
Clinical Details
Official title: The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Ulcer size
Secondary outcome: Erythema
Eligibility
Minimum age: 12 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Texas A&M Baylor College of Dentisry, Dallas, Texas 75246, United States
Additional Information
Starting date: March 2012
Last updated: June 4, 2014
|