- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02642900
Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers
Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Different Candida species, including albicans, tropicalis, and parapsilosis, are present in the human oral microbiota, gastrointestinal tract and vagina. These species are typically harmless commensals. Candida albicans, the most prevalent species, may be present in up to 80% of healthy individuals. This species is found with high frequency in dental prostheses and is thought to be the main pathogen associated with stomatitis in elderly denture wearers. Biofilms of Candida albicans are usually found in intravenous catheters, prostheses, and these biofilms promote a high resistance to antifungal drugs. The standard treatment of stomatitis is topical antifungal agents, including nystatin and miconazole. The use of topical antifungal agents has caused some problems. Poor responses to these agents are the result of dilution and fast elimination of the drug because of the action of the saliva, which reduced the drug's concentration. The drug's toxicity can cause mild and transient gastrointestinal side effects, such as nausea, vomiting and diarrhea. Alternative treatments or adjuvant treatments have been used to treat these diseases, such as the use of probiotic bacteria and photodynamic therapy (PDT) using a non-toxic dye (photosensitizer - PS) in combination with a source of visible light with a peak wavelength suitable for absorption by the PS. The photodynamic process rapidly generates reactive oxygen species (ROS) such as peroxides, hydroxyl radicals, superoxide ions and singlet oxygen. Singlet oxygen has been implicated as the major causative agent of cellular damage in the photodynamic process, but it does not cause cellular damage in host tissues. The amount of ROS formation is the main predictor of yeast killing.
This study aimed to evaluate the effectiveness of photodynamic therapy (PDT) in the treatment of denture stomatitis in complete denture wearers.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05508-000
- Faculdade de Odontologia da Universidade de são Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients presenting denture-related stomatitis, confirmed by clinical and microbiological evaluation
Exclusion Criteria:
- were based on the patients' medical history, and were excluded patients with a history of head and neck cancer, those with type III DS (classification proposed by Newton), and individuals who had received or were receiving treatment with antibiotics, antifungal agents or steroids for the past three months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nystatin 100.000 units
Patients were treated with a topical antifungal nystatin oral suspension(1000.000
units) 5mL every six hours/14 days.
Patients were instructed to rinse the solution for 5 minutes and then to spit the solution out.
Samples were collected on days 7, 14 and 30 after the end of treatment (follow-up).
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Control group treated with nystatin
Other Names:
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Active Comparator: Photodynamic Therapy
Patients used mouthwash with methylene blue 0.005% for 20 minutes (pre-irradiation time).
The palatal mucosa was irradiated using a low level laser with the following settings: wavelength of 660 nm, energy density of 120 J/cm ², output power of 40 milliwatt, 2 minutes per point.
PDT was performed in two sessions (one session per week).
Samples were collected immediately after each clinical procedure and 30 days after the second procedure (follow-up).
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evaluate the effectiveness of photodynamic therapy (PDT) in the treatment of denture stomatitis in complete denture wearers.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment evolution of participants with Candida-related denture stomatitis, treated with PDT or Nystatin, by numbers of colony forming units per milliliter (cfu/mL) recovered from the palatal mucosa, from baseline to end of treatment
Time Frame: through study completion, an average of 45 days
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through study completion, an average of 45 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Regina Tamaki, Profa. Dra., Associated Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DML01
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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