Randomized clinical trial, double-blind, crossover for evaluation of an experimental solution based on Ricinus communis and sodium hypochlorite for denture cleansing.

Abstract

This randomized clinical trial, double-blind, crossover has as primary objective to evaluate clinically an experimental solution based on Ricinus communis 10% and sodium hypochlorite (0.25% and 0.5%). As secondary objective, this study will evaluate the effect of solutions on the surface roughness of acrylic resin in vitro. As clinical variables, will be measured the effectiveness of the solutions on biofilm removal from the inner surface of maxillary dentures, remission of chronic atrophic candidiasis, the reduction of viable microorganisms biofilm and degree of patient satisfaction. The laboratory variable will be the surface roughness of the acrylic resin after the use of solutions. For clinical analysis, fourty patients users dentures will be divided into two groups: G1 - without chronic atrophic candidiasis, G2 - with atrophic chronic candidiasis. All volunteers from both groups will receive the following guidelines: brushing the dentures (special brush and liquid soap) for 20 minutes and immersion in the solutions: S1 - distilled water (control), S2 - sodium hypochlorite at 0.25%; S3 - sodium hypochlorite at 0.5% and S4 - Ricinus communis at 10%. These solutions will be used in a cross-over model for all patients during 07 days in a randomized sequence and a washout period of 07 days will be established between the solutions. At the end of each period, the inner surface of the prosthesis will be evidenced (1% neutral red) and photographed for the quantification of the biofilm by means of software ImageTool 3.0.Remission of chronic atrophic candidiasis of the G2 will be evaluated based on standardized images of the palate before and after use of each solution by assigning scores. Microbiological analysis of biofilm samples collected from the inner surface of the prosthesis after the use of solutions will be realized by DNA checkerboard hybridization technique. Finally, a questionnaire will be used to check patients' satisfaction regarding the use of each solution. For laboratory tests, the roughness will be measured (RI) before intervention in 40 specimens (90 x 30 x 4mm) of heat-polymerized acrylic resin. The specimens will be brushed three times a day for 3 minutes, immersed in the solutions for 20 minutes, rinsed and stored in artificial saliva during the intervals between the interventions. The trial period will be 21 days, with the roughness reading every 07 days. Then the specimens will be evaluated with scanning electron microscopy and this analysis will be qualitative. The solutions ability of biofilm removal will be evaluated by ANOVA (Two-way: solutions and groups) and Tukey's test. The candidiasis' remission will be analyzed by ANOVA (One-way) and Tukey's test. Microbiological data are transformed to log10 and analyzed using ANOVA (Two-way: solutions and groups). The analysis of the patients' satisfaction regarding the solutions will be performed in a descriptive way. The roughness data will be analyzed by ANOVA (Two-Way: Solutions and time) and Tukey's test. All analyzes will be conducted at 5% probability. (AU)