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

NCT04532060 | Completed Phase 2 DMC

• 1 other identifier: FoAr
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Health Care Associated Infection

Outcome Measures

Primary Outcomes (5)

• 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.

  The recovery of microorganisms was performed before the tretaments (at the baseline - initial).

• 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.

  The recovery of microorganisms was performed immediately at the end of the treatments.

• 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.

  The recovery of microorganisms was performed on day 15 after the end of the treatments.

• 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.

  The recovery of microorganisms was performed on day 30 after the end of the treatments.

• 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.

  The recovery of microorganisms was performed on day 45 after the end of the treatments.

Secondary Outcomes (1)

• Clinical evaluation

  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.

Study Arms (2)

Antimicrobial Photodynamic Therapy

EXPERIMENTAL

Patients treated with Antimicrobial Photodynamic Therapy

Procedure: Antimicrobial Photodynamic Therapy

Nystatin

EXPERIMENTAL

Patients treated with Nystatin antifungal drug.

Drug: Nystatin

Interventions

Nystatin DRUG

Nystatin

Antimicrobial Photodynamic Therapy PROCEDURE

Antimicrobial Photodynamic Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Edentulous denture wearers clinically diagnosed with denture stomatitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• São Paulo State University: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Cross Infection

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 31, 2020
• Study Start: February 1, 2015
• Primary Completion: May 2, 2015
• Study Completion: May 2, 2017
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share