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Trial record 78 of 215 for:    TETRACYCLINE

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

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ClinicalTrials.gov Identifier: NCT02142543
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Texas A&M University

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.

Condition or disease Intervention/treatment Phase
Minor Recurrent Aphthous Stomatitis Lesions Drug: 2-DeNT powder Drug: Placebo Comparator Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

Arm Intervention/treatment
Placebo Comparator: placebo
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
Drug: Placebo Comparator
Other Name: placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder

Experimental: 2-DeNT powder
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
Drug: 2-DeNT powder
powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Pain [ Time Frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days ]
    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"



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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142543


Locations
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United States, Texas
Texas A&M Baylor College of Dentisry
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Texas A&M University

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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT02142543     History of Changes
Other Study ID Numbers: BCDOrtho1
2011-23-BCD ( Other Identifier: IRB number )
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Zinc Oxide
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents