Randomized, double-blind, placebo-controlled trial to test the efficacy of nitradine tablets in maxillary removable orthodontic appliance patients.

OBJECTIVE: to evaluate the efficiency of NitrAdine (MSI Laboratories) tablets in the reduction of oral Candida levels, biofilm formation, and appliance odor in maxillary removable orthodontic appliance wearers. METHOD AND MATERIALS: seventy children between 11 and 15 years of age undergoing maxillary removable appliance treatment were assigned via a double-blind randomized method to the experimental or placebo arm of the study. One milliliter of unstimulated saliva was collected at the beginning of the experiment and 6 weeks later after treatment of the maxillary removable appliance with NitrAdine tablets. Samples were cultured on chromogenic Candida agar, and the number of colony-forming units per mL of saliva (CFU mL-1) was determined.
RESULTS: there was no significant difference in salivary Candida levels before or after treatment with NitrAdine tablets. There was a significant drop in plaque accumulation on the appliance and a significant amelioration in appliance odor. There was a small, nonsignificant drop in individuals exhibiting counts of 400 CFU mL-1 or more in the experimental group and a nonsignificant increase in the number of new species in the placebo group.
CONCLUSIONS: NitrAdine tablets are effective in reducing plaque accumulation and appliance odor during maxillary removable appliance treatment. Further in vivo studies are required to determine the efficacy and exact protocol for NitrAdine tablets in appliance disinfection.

RCT Entities:   Population Interventions Outcomes