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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-23-BCD | Other Identifier | IRB number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder, applied twice a day until the ulcer had resolved, an expected average of 3-5 days |
|
| 2-DeNT powder | Experimental | 2-DeNT powder containing dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum, applied twice a day until the ulcer had resolved, applied twice a day until the ulcer had resolved, in an expected average of 3 to 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-DeNT powder | Drug | powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer size | 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. | From time of randomization until ulcer was healed, an expected average of 3 to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema | 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 | From time of randomization until ulcer was healed, an expected average of 3 to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | The perceived level of pain or discomfort was noted by the subject using a 10 cm visual analogue scale (VAS) with anchors of "no pain" and "worst pain ever" | From time of randomization until ulcer was healed, an expected average of 3 to 5 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M Baylor College of Dentisry | Dallas | Texas | 75246 | United States |
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| ID | Term |
|---|---|
| D007618 | Karaya Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Placebo Comparator | Drug |
|
|
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |