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| Name | Class |
|---|---|
| Texas A&M University | OTHER |
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CelAgace⢠OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.
CelAgace⢠contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silver citrate complex and acemannan | Experimental | This is a single arm open pilot trial. All participants will receive study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver citrate complex and acemannan | Drug | Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture | Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation. | Days 1(Baseline), 3, 7 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Pain | Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study. | Days 1, 3, 7, 14 |
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Inclusion Criteria:
Exclusion Criteria:
Patient:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline M. Plemons, DDS, MS | Contact | 214-828-8467 | jplemons@tamhsc.edu | |
| Celeste M. Abraham, DDS, MS | Contact | 214-828-8467 | cabraham@tamhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline M. Plemons, DDS, MS | Texas A&M University College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M University College of Dentistry | Dallas | Texas | 75246 | United States |
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| ID | Term |
|---|---|
| D002180 | Candidiasis, Oral |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C058414 | acemannan |
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|
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |