search
Back to results

Effectiveness of Hygiene Solutions on Denture Biofilm

Primary Purpose

Stomatitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
S1
S2
S3
S4
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stomatitis focused on measuring Biofilms, Dentures, Denture Cleansers, Castor Oil, Stomatitis

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm.

Exclusion Criteria:

  • Problems in adapting, reline, or repair fractures
  • Patients with limited communication or collaboration as the following recommended protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    S1 - 0.25% sodium hypochlorite

    S2 - 0.5% sodium hypochlorite

    S3 - 10% Ricinus communis

    S4 - saline solution

    Arm Description

    Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.25% sodium hypochlorite during 20 minutes, once a day. This protocol was used during 7 days.

    Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.5% sodium hypochlorite during 20 minutes, once a day.This protocol was used during 7 days.

    Brushing with specific brush and neutral soap, three times a day. After, immesion in 10% Ricinus communis solution during 20 minutes, once a day. This protocol was used during 7 days.

    Brushing with specific brush and neutral soap, three times a day. After, immesion in saline solution during 20 minutes, once a day. This protocol was used during 7 days.

    Outcomes

    Primary Outcome Measures

    biofilm removal capacity using Image Tool software
    antimicrobial action against specific microorganisms by Colony Forming Units counts

    Secondary Outcome Measures

    remission of atrophic chronic candidiasis using multinomial logistic regression analysis
    degree of patient satisfaction assessed by specific questionnaire

    Full Information

    First Posted
    February 9, 2015
    Last Updated
    April 2, 2015
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02407834
    Brief Title
    Effectiveness of Hygiene Solutions on Denture Biofilm
    Official Title
    Clinical Evaluation of an Experimental Solution Based on Ricinus Communis Compared to Sodium Hypochlorite for Denture Cleansing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different concentrations for denture cleanliness, regarding biofilm removal capacity, remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4: control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind and cross form with washout periods. 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. Patient satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, internal surface of each maxillary complete denture was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two variation factors: inflammation and solutions. The candidiasis remission was analyzed after adjustment using multinomial logistic regression. Logistic regression analysis and compound symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU + 1) - and were analyzed by Friedman test (α = 0.05).
    Detailed Description
    Sixty-four denture wearers with (n=24) and without Candidiasis (n=40) were enrolled and instructed to brush and immerse their dentures in 4 different storage solutions (S1: 0.25% sodium hypochlorite; S2: 0.5% sodium hypochlorite; S3: 10% R. communis; and S4: Saline/Control). The interventions were randomly performed in a double blind and crossover format with washout periods. After 7 days of brushing and storage, the biofilm formed in the inner surfaces of dentures was disclosed and photographed to quantification. Candidiasis remission was assessed by scores and the patient satisfaction by a questionnaire. Antimicrobial activity of the solutions was determined by counting the Colony Forming Units (CFUs) of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, each complete upper denture was placed in a Petri dish, its internal surface was brushed (Tek brush) with saline solution for 2 min, and the biofilm suspension was transferred to a test tube. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomatitis
    Keywords
    Biofilms, Dentures, Denture Cleansers, Castor Oil, Stomatitis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    S1 - 0.25% sodium hypochlorite
    Arm Type
    Experimental
    Arm Description
    Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.25% sodium hypochlorite during 20 minutes, once a day. This protocol was used during 7 days.
    Arm Title
    S2 - 0.5% sodium hypochlorite
    Arm Type
    Experimental
    Arm Description
    Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.5% sodium hypochlorite during 20 minutes, once a day.This protocol was used during 7 days.
    Arm Title
    S3 - 10% Ricinus communis
    Arm Type
    Experimental
    Arm Description
    Brushing with specific brush and neutral soap, three times a day. After, immesion in 10% Ricinus communis solution during 20 minutes, once a day. This protocol was used during 7 days.
    Arm Title
    S4 - saline solution
    Arm Type
    Placebo Comparator
    Arm Description
    Brushing with specific brush and neutral soap, three times a day. After, immesion in saline solution during 20 minutes, once a day. This protocol was used during 7 days.
    Intervention Type
    Other
    Intervention Name(s)
    S1
    Other Intervention Name(s)
    0.25% sodium hypochlorite
    Intervention Description
    Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.
    Intervention Type
    Other
    Intervention Name(s)
    S2
    Other Intervention Name(s)
    0.5% sodium hypochlorite
    Intervention Description
    Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.
    Intervention Type
    Other
    Intervention Name(s)
    S3
    Other Intervention Name(s)
    10% ricinus communis
    Intervention Description
    Immersion in 10% Ricinus communis for 20 minutes, during 7 days.
    Intervention Type
    Other
    Intervention Name(s)
    S4
    Other Intervention Name(s)
    saline solution
    Intervention Description
    Immersion in Saline solution for 20 minutes, during 7 days.
    Primary Outcome Measure Information:
    Title
    biofilm removal capacity using Image Tool software
    Time Frame
    7 days
    Title
    antimicrobial action against specific microorganisms by Colony Forming Units counts
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    remission of atrophic chronic candidiasis using multinomial logistic regression analysis
    Time Frame
    7 days
    Title
    degree of patient satisfaction assessed by specific questionnaire
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm. Exclusion Criteria: Problems in adapting, reline, or repair fractures Patients with limited communication or collaboration as the following recommended protocol.

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of Hygiene Solutions on Denture Biofilm

    We'll reach out to this number within 24 hrs