Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2016-07-01

Brief Summary

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This clinical study identified the Candida species from the palate and complete dentures of edentulous individuals with prostheses-related stomatitis (PRS) and evaluated the effect of disinfectant solutions for denture hygiene on Candida spp. Sixty participants were randomly assigned in 04 parallel groups (n = 15); They were oriented to brush their prostheses and the palate 3 times a day and immerse them in saline solution (C-control), 0.25% Sodium hypochlorite (HS0.25%), 10% Ricinus communis (RC10%) or 0.5% Chloramine T (CT 0.5%) for 20 minutes. Biofilm samples were collected from the prostheses and palate in the baseline, after 7 and 37 days of use of the solutions and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. To quantify biofilm with software ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end of each period. The Candidiasis remission was assessed by scores before and after the use of solutions by palate's phographs. Descriptive analyzes were used for the identification and incidence of Candida spp. Kruskal-Wallis and Friedman tests, with stepwise step-down post-test for cell growth; ANOVA and Tukey for biofilm removal; Frequency of scores for evolution of inflammation. Level of significance was 95%. The most incident species were C. albicans, followed by C. tropicalis, C. glabrata and C. krusei. HS 0.25% reduced the incidence of the three species on the prostheses and palate in the periods of 7 and 37 days; CT 0.5% promoted reduction of Candida spp. only in dentures. R. communis decreased the incidence of C. tropicalis in both collection sites. For CFU counts, HS 0.25% and CT 0.5% caused significant reduction. For biofilm removal, HS0.25% was the most effective (9.75 ± 12.6) and RC10% (15.92 ± 14.8) intermediate. All groups decreased protheses-related stomatitis. HS0.25% has potential for clinical use as total denture disinfectants. RC10% and CT0.5% require further studies to be indicated as alternative solutions.

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Detailed Description

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Conditions

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Candidiasis Biofilms Candida Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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C; Control; Saline solution

Disinfection protocol:

* brushing the palate (3 times a day/ 2 minutes);
* brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes);
* immersing the total prostheses in Saline solution (once a day/ 20 minutes) before the last brushing of the day;
* the prostheses must be conditioned in a vessel with water during the whole night period.

Periods of analysis (Baseline, 7 and 37 days):

* the prostheses will be evidenced and photographed.
* the biofilm present on the inner surface of the prostheses will be collected;
* photographe of the participants' palate;
* collected the palate biofilm.

Group Type PLACEBO_COMPARATOR