Treatment of Candida-infected denture stomatitis with a miconazole lacquer.

The efficacy of a topically administered miconazole denture lacquer was compared with that of a placebo lacquer in the treatment of Candida-infected denture stomatitis. The study was a double-blind, randomized, controlled clinical trial with two parallel treatment groups. The lacquer was applied once on the fitting denture surface. Follow-up examinations took place on days 3, 7, 14, 21, 28, and 35. On day 14 the effect of the treatment was assessed. Thirty-six patients were included in the statistical analysis. Eighteen received miconazole and 18 received placebo lacquer. Primary efficacy endpoints were the number of colonies cultured from the palatal mucosa and denture surface on day 14. Thirteen of 16 patients in the miconazole group A showed < 10 colonies on culture medium on day 14 in the specimens from the palatal mucosa as did 5 of 18 patients in the placebo group B (p < 0.05). Corresponding results for the denture surface were 6 of 17 and 3 of 18, respectively (p < 0.05). Reapplication of lacquer was considered necessary (> 100 colonies in at least one sampling site within 14 days) in 35% of the patients from group A and in 83% of the patients from group B. The results indicate that a single application of a miconazole denture lacquer considerably reduces the number of Candida yeasts for a substantial period of time.

RCT Entities:   Population Interventions Outcomes