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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
Texas A&M University College of Dentistry
Dallas, Texas, United States
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.
Time frame: Days 1(Baseline), 3, 7 and 14
Reduction in Pain
Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
Time frame: Days 1, 3, 7, 14
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