Clinical evaluation of a nystatin pastille for treatment of denture-related oral candidiasis.
Nystatin has been formulated in the form of a flavored pastille (troche) as an alternative to the oral suspension. This parallel, double-blind, randomized, placebo-controlled study evaluated the acceptance and effectiveness of the nystatin pastille at two different dosages. Twenty-four subjects were selected on the basis of clinical signs of denture stomatitis and culture isolation of Candida spp. Each subject was randomly assigned to one of three treatment groups (A, 200,000 units; B, 400,000 units; and C, placebo). At entry, 7 days, 14 days, and at 10 days after cessation of treatment, the clinical condition was evaluated and Gram stain smears and imprint cultures were made and analyzed. The flavored pastille was well accepted by the subjects and both dosages were shown to be effective in significantly reducing or eliminating the Candida organism during active therapy. Data from the 10-day follow-up, however, demonstrated reinfection with the organism. Thus to resolve the condition, effective therapy must include treatment of the etiologic factors of denture stomatitis along with antimicrobial therapy.