Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers
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|ClinicalTrials.gov Identifier: NCT02642900|
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : December 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Photochemotherapy Reaction||Procedure: Photodynamic Therapy Drug: Nystatin 100.000 units||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers: a Randomized Clinical Trial|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||July 2011|
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).
Drug: Nystatin 100.000 units
Control group treated with nystatin
Other Name: Nystatin
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).
Procedure: Photodynamic Therapy
evaluate the effectiveness of photodynamic therapy (PDT) in the treatment of denture stomatitis in complete denture wearers.
Other Name: photochemotherapy
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642900
|Faculdade de Odontologia da Universidade de São Paulo|
|São Paulo, Brazil, 05508-000|
|Principal Investigator:||Regina Tamaki, Profa. Dra.||Associated Professor|