Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Phase 4

Completed

• Conditions: Photochemotherapy Reaction
• Interventions: Procedure: Photodynamic Therapy; Drug: Nystatin 100.000 units

• Registration Number: NCT02642900
• Lead Sponsor: University of Sao Paulo

Brief Summary

Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are several treatment options for this condition, including the use of antifungal agents such as nystatin and miconazole. The side effects and the increasing number of resistant species caused by the use of these drugs encourage the development of alternative therapies. Photodynamic Therapy (PDT) has been used as a promising treatment of stomatitis. In this randomized clinical trial, the effectiveness of PDT was evaluated. Patients in this study were allocated to two groups. One group was treated with nystatin, and the other group was treated with PDT.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-02
• Study Completion: 2011-07
• Study First Submitted: 2015-10-07
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-25
• Last Update Submitted: 2015-12-25
• Study First Posted: 2015-12-30
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• patients presenting denture-related stomatitis, confirmed by clinical and microbiological evaluation

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy	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).
Nystatin 100.000 units	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).

Primary Outcome Measures

Name	Time	Method
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	through study completion, an average of 45 days

Trial Locations

Locations (1)

Faculdade de Odontologia da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil