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临床试验/NCT03203551
NCT03203551已完成不适用

Clinical and Laboratorial Evaluation of the Effect of Sodium Hypochlorite, Chloramine T and Ricinus Communis Solutions in Candida Species Identified in the Biofilm of Total Prostheses and Palate of Total Edentulous Individuals.

University of Sao Paulo0 个研究点目标入组 108 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
主要终点
Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.

时间窗: 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.

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cláudia Helena Lovato da Silva

Principal Investigator and Clinical Professor

University of Sao Paulo

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