Clinical evaluation of the Photodynamic Therapy efficacy, mediated by Photodithazine®,in the treatment of denture stomatitis.

Abstract

The aim of this clinical study is to evaluate the effect of Photodynamic Therapy (PDT) as a treatment for patients with denture stomatitis, using Photodithazine (PDZ) as photosensitizer associated with LED light (660 nm)in a dose of 37.5 J/cm2 . Additionally, it will be identified and quantified the microrganisms and evaluated the effect of PDT on disinfection of maxillary dentures of these patients . For that, 60 denture wearers with denture stomatitis clinical diagnosed will be randomly assigned to 2 groups (n = 30), according to established treatment : Group 1 (Control - NYS G) - cleaning treatment, immersion of the dentures at nocturnal period in water and in topical antifungal nystatin (oral suspension), 4 times a day for 15 days , Group 2 (Experimental -PDT G) - cleaning treatment, immersion of the dentures in water at night, application of PDT in the palate 3 times a week, and also irradiation of the dentures 3 times per week for 15 days. To establish a parameter in the long term, all patients will be followed for 60 days after initiating treatments. To evaluate the effectiveness of treatment, at baseline (day 0), at the end of the treatment (day 15) and at the follow-up time intervals (days 30, 45 ad 60), the patients will be submitted to the follow protocols: collections of mycological material from dentures and palatal mucosa , intra oral photos of the palates , quantification of viable colonies and identification of Candida species by real - time PCR . Two specialists will analyse the photographs taken and will evaluate the level of the infection, unaware the treatment. The results obtained pre-treatment, treatment and post end of treatment (30, 45 and 60 days) will be compared and statistically analyzed.