Back to resultsThe Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Primary Purpose
Minor Recurrent Aphthous Stomatitis Lesions
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
2-DeNT powder
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Minor Recurrent Aphthous Stomatitis Lesions
Eligibility 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.
Sites / Locations
- Texas A&M Baylor College of Dentisry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
2-DeNT powder
Arm Description
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 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02142543
Brief Title
The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Official Title
The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas A&M University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minor Recurrent Aphthous Stomatitis Lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
2-DeNT powder
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
2-DeNT powder
Intervention Description
powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder
Primary Outcome Measure Information:
Title
Ulcer size
Description
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.
Time Frame
From time of randomization until ulcer was healed, an expected average of 3 to 5 days
Secondary Outcome Measure Information:
Title
Erythema
Description
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
Time Frame
From time of randomization until ulcer was healed, an expected average of 3 to 5 days
Other Pre-specified Outcome Measures:
Title
Pain
Description
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"
Time Frame
From time of randomization until ulcer was healed, an expected average of 3 to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Texas A&M Baylor College of Dentisry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
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