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

Not Applicable

Completed

• Conditions: Candidiasis; Candida Infection; Biofilms
• Interventions: Other: Disinfection Protocol

• Registration Number: NCT03203551
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2016-01-01
• Study Completion: 2016-07-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-29
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT0.5%; 0.5% Chloramine T	Disinfection Protocol	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 0.5% Choramine T (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.
C; Control; Saline solution	Disinfection Protocol	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.
HS0.25%; 0.25% Sodium Hypochlorite	Disinfection Protocol	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 0.25% Sodium Hypochlorite (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.
RC10%; 10% Ricinus communis	Disinfection Protocol	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 10% Ricinus communis (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.

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.	Baseline (without disinfection procedures)	Biofilm samples were collected from the prosthesis and palate in the baseline and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. The inner surface of the denture was disclosed (1% neutral red) and photographed at the end to quantify the biofilm with the software ImageTool 3.0. The palate with Candidiasis was photographed and assessed by scores.

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation of the effect of Sodium hypochlorite, Chloramine T and Ricinus communis solutions after 7 days of use in Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.	7 days of disinfection	Biofilm samples were collected from the prostheses and palate after 7 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 the denture biofilm with software ImageTool 3.0, the inner surface of the denture was disclosed (1% neutral red) and photographed at the end of 7 days. The Candidiasis remission was photographed and assessed by scores after 7 days of use solutions.
Clinical evaluation of the effect of Sodium hypochlorite, Chloramine T and Ricinus communis solutions after 37 days of use in Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.	37 days of disinfection	Biofilm samples were collected from the prostheses and palate after 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 the denture biofilm with software ImageTool 3.0, the inner surface of the denture was disclosed (1% neutral red) and photographed at the end of 37 days. The Candidiasis remission was photographed and assessed by scores after 37 days of use solutions.