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Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis

Primary Purpose

Health Care Associated Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nystatin
Antimicrobial Photodynamic Therapy
Sponsored by
São Paulo State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Health Care Associated Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Edentulous denture wearers clinically diagnosed with denture stomatitis.

Exclusion Criteria:

  • patients who received antibiotics, antifungal or steroids in the past 3 months prior to the beginning of the research, women in the reproductive phase, patients who had worn the same denture in the past 10 years, diabetics, anemics, immunocompromised and under cancer treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Antimicrobial Photodynamic Therapy

    Nystatin

    Arm Description

    Patients treated with Antimicrobial Photodynamic Therapy

    Patients treated with Nystatin antifungal drug.

    Outcomes

    Primary Outcome Measures

    Microbial Viability at baseline
    The efficacy of the treatments was verified microbiologically at the baseline (initial). For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Microbial Viability at the end of the treatments
    The efficacy of the treatments was verified microbiologically immediately at the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Microbial Viability on day 15
    The efficacy of the treatments was verified microbiologically on day 15 after the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Microbial Viability on day 30
    The efficacy of the treatments was verified microbiologically on day 30 after the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Microbial Viability on day 45
    The efficacy of the treatments was verified microbiologically on day 45 after the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.

    Secondary Outcome Measures

    Clinical evaluation
    To verify the clinical efficacy of the treatments, the oral lesions on the palatal mucosal were evaluated. For this, standardized photographs of the palates were taken prior to the beginning of the treatments (initial) and up to 45 days after the end of the treatments. All the photographs were taken with the same digital camera (NIKON D7000, Tokyo, Japan), by the same operator, under the same conditions (place, light, position). After that, all photographs were analyzed by two individuals blinded to the treatment performed, to classify the oral lesion in type I, II or III in all time intervals.

    Full Information

    First Posted
    July 28, 2020
    Last Updated
    August 25, 2020
    Sponsor
    São Paulo State University
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04532060
    Brief Title
    Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
    Official Title
    A Randomized Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2015 (Actual)
    Primary Completion Date
    May 2, 2015 (Actual)
    Study Completion Date
    May 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    São Paulo State University
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São 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
    Objective: This randomized clinical trial assessed antimicrobial Photodynamic Therapy (aPDT) mediated by Photodithazine (PDZ) to treat patients with denture stomatitis (DS). Methodologies: Patients with DS were randomly assigned to the groups: aPDT (n=30) and nystatin (NYS, n=35). aPDT patients received 6 aPDT sessions, three times a week for 15 days, which involved PDZ (200 mg/L) topical application (20 min) on the palate and upper denture, followed by light emitting diode (LED) illumination (660 nm, 50 J/cm²). NYS patients were instructed to rinse one dropper of this medication for one minute, four times a day, for 15 days. Microbiological collections of dentures and palates were performed and cultured on blood agar and CHROMAgar Candida. Microbial viability was determined, and photographs of the palates were taken for clinical evaluation. Data were analyzed by Repeated Measure Linear Model and Bonferroni (p≤0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Care Associated Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antimicrobial Photodynamic Therapy
    Arm Type
    Experimental
    Arm Description
    Patients treated with Antimicrobial Photodynamic Therapy
    Arm Title
    Nystatin
    Arm Type
    Experimental
    Arm Description
    Patients treated with Nystatin antifungal drug.
    Intervention Type
    Drug
    Intervention Name(s)
    Nystatin
    Intervention Type
    Procedure
    Intervention Name(s)
    Antimicrobial Photodynamic Therapy
    Primary Outcome Measure Information:
    Title
    Microbial Viability at baseline
    Description
    The efficacy of the treatments was verified microbiologically at the baseline (initial). For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Time Frame
    The recovery of microorganisms was performed before the tretaments (at the baseline - initial).
    Title
    Microbial Viability at the end of the treatments
    Description
    The efficacy of the treatments was verified microbiologically immediately at the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Time Frame
    The recovery of microorganisms was performed immediately at the end of the treatments.
    Title
    Microbial Viability on day 15
    Description
    The efficacy of the treatments was verified microbiologically on day 15 after the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Time Frame
    The recovery of microorganisms was performed on day 15 after the end of the treatments.
    Title
    Microbial Viability on day 30
    Description
    The efficacy of the treatments was verified microbiologically on day 30 after the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Time Frame
    The recovery of microorganisms was performed on day 30 after the end of the treatments.
    Title
    Microbial Viability on day 45
    Description
    The efficacy of the treatments was verified microbiologically on day 45 after the end of the treatments. For each patient, oral swabs were rubbed onto the palatal mucosa and on the tissue surface of the denture for 1 minute to recover the microorganisms. Each swab was placed into a Falcon tube (Corning, New York, USA) containing 5 mL of 0.9% sterile saline solution and vortexed for 1 minute to suspend the microorganisms from the swab. To evaluate Candida spp. survival and to presumptively identify Candida species by colony color, serial 10-fold dilutions from 100 to 103 were plated in duplicate on Chromagar Candida and incubated at 30 °C for 5 days. Additionally, to assess the total microbiota survival (fungal and bacteria), serial 10-fold dilutions from 102 to 104 were plated onto Blood agar.
    Time Frame
    The recovery of microorganisms was performed on day 45 after the end of the treatments.
    Secondary Outcome Measure Information:
    Title
    Clinical evaluation
    Description
    To verify the clinical efficacy of the treatments, the oral lesions on the palatal mucosal were evaluated. For this, standardized photographs of the palates were taken prior to the beginning of the treatments (initial) and up to 45 days after the end of the treatments. All the photographs were taken with the same digital camera (NIKON D7000, Tokyo, Japan), by the same operator, under the same conditions (place, light, position). After that, all photographs were analyzed by two individuals blinded to the treatment performed, to classify the oral lesion in type I, II or III in all time intervals.
    Time Frame
    Standardized photographs of the palates were taken prior to the beginning of the treatments (initial) and up to 45 days after the end of the treatments.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Edentulous denture wearers clinically diagnosed with denture stomatitis. Exclusion Criteria: patients who received antibiotics, antifungal or steroids in the past 3 months prior to the beginning of the research, women in the reproductive phase, patients who had worn the same denture in the past 10 years, diabetics, anemics, immunocompromised and under cancer treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis

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