- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532060
Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
August 25, 2020 updated by: São Paulo State University
A Randomized Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antimicrobial Photodynamic Therapy
Patients treated with Antimicrobial Photodynamic Therapy
|
|
Experimental: Nystatin
Patients treated with Nystatin antifungal drug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbial Viability at baseline
Time Frame: The recovery of microorganisms was performed before the tretaments (at the baseline - initial).
|
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
Time Frame: The recovery of microorganisms was performed immediately 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
Time Frame: The recovery of microorganisms was performed on day 15 after the end of the treatments.
|
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
Time Frame: The recovery of microorganisms was performed on day 30 after the end of the treatments.
|
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
Time Frame: The recovery of microorganisms was performed on day 45 after the end of the treatments.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical evaluation
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
May 2, 2015
Study Completion (Actual)
May 2, 2017
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
August 25, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Actual)
August 31, 2020
Last Update Submitted That Met QC Criteria
August 25, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Disease Attributes
- Stomatognathic Diseases
- Mouth Diseases
- Iatrogenic Disease
- Stomatitis
- Cross Infection
- Stomatitis, Denture
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Antifungal Agents
- Ionophores
- Anti-Bacterial Agents
- Anti-Infective Agents
- Nystatin
Other Study ID Numbers
- FoAr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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