An Early Phase 1 interventional study of 2-DeNT powder and Placebo Comparator in Minor Recurrent Aphthous Stomatitis Lesions, sponsored by Texas A&M University. Completed at 1 site in United States. Open to participants aged 12 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-06.
Sponsored by Texas A&M University · Early Phase 1, Interventional, and Treatment
Among 10 studies in Stomatitis, Aphthous with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Stomatitis, Aphthous · United States.
Among the 10 studies in Stomatitis, Aphthous with a site in United States, this one is the only one that started in 2012, is the only one in phase 1, and was the 6th registered.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 23 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →2 of the 10 studies in Stomatitis, Aphthous with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 7 Stomatitis, Aphthous studies recruiting now, 3 (43%) set no upper age limit and 2 (29%) stop at 75 or younger; 3 take children under 18; 1 take healthy volunteers.
This study: 12 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 1 started in 2012.
Median enrollment 30 across the 9 interventional studies, 1,500 across the 1 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
1 of 10 have an industry lead sponsor. The 8 most frequent:
Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Texas A&M University has 1 study filed under Stomatitis, Aphthous — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Stomatitis, Aphthous with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder
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.
Time frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
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
Time frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
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"
Time frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
The record gives a start of Mar 2012, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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