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

Primary Purpose

Candidiasis, Biofilms, Candida Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Disinfection Protocol
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Candidiasis focused on measuring Dentures, Biofilms, Disinfection, Candidiasis, Candida

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • providing consent prior to participation in the study;
  • being at least 18 years of age;
  • maxillary complete conventional denture in good state and 1 year of use;
  • dentures with biofilm in a internal surface;
  • moderate to severe signs of Candidiasis.

Exclusion criteria:

  • presence oral mucosal lesions apart from Candidiasis;
  • systemic or local conditions which predispose to Candida spp. infection;
  • history of chemotherapy/ radiotherapy;
  • having taken or used antibiotics, steroidal agents, or antifungal agents in the three months prior to the study;
  • being scheduled to replace existing dentures with new ones during the period of the trial;
  • dentures with adaptation or retention problems;
  • already using palatal brushing or disinfectant solutions as a routine oral hygiene.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    C; Control; Saline solution

    HS0.25%; 0.25% Sodium Hypochlorite

    RC10%; 10% Ricinus communis

    CT0.5%; 0.5% Chloramine T

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    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.
    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.
    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.

    Full Information

    First Posted
    June 23, 2017
    Last Updated
    June 29, 2017
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03203551
    Brief Title
    Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous.
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2016 (Actual)
    Study Completion Date
    July 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Candidiasis, Biofilms, Candida Infection
    Keywords
    Dentures, Biofilms, Disinfection, Candidiasis, Candida

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    C; Control; Saline solution
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    HS0.25%; 0.25% Sodium Hypochlorite
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    RC10%; 10% Ricinus communis
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    CT0.5%; 0.5% Chloramine T
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Disinfection Protocol
    Other Intervention Name(s)
    Denture Hygiene Protocol
    Intervention Description
    The participants assigned to this group carried out the disinfection protocol that recommended brushing the palate (3 times a day), brushing the total prosthesis with neutral liquid soap (3 times a day) and immersing in different desinfection solutions (once a day/ 20 minutes)
    Primary Outcome Measure Information:
    Title
    Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
    Description
    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.
    Time Frame
    Baseline (without disinfection procedures)
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    7 days of disinfection
    Title
    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.
    Description
    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.
    Time Frame
    37 days of disinfection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: providing consent prior to participation in the study; being at least 18 years of age; maxillary complete conventional denture in good state and 1 year of use; dentures with biofilm in a internal surface; moderate to severe signs of Candidiasis. Exclusion criteria: presence oral mucosal lesions apart from Candidiasis; systemic or local conditions which predispose to Candida spp. infection; history of chemotherapy/ radiotherapy; having taken or used antibiotics, steroidal agents, or antifungal agents in the three months prior to the study; being scheduled to replace existing dentures with new ones during the period of the trial; dentures with adaptation or retention problems; already using palatal brushing or disinfectant solutions as a routine oral hygiene.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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