Skip to content

Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers: a Randomized Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02642900
Enrollment
22
Registered
2015-12-30
Start date
2009-07-31
Completion date
2011-07-31
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photochemotherapy Reaction

Keywords

Complete denture, Candida spp, Photodynamic therapy

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.

Interventions

PROCEDUREPhotodynamic Therapy

evaluate the effectiveness of photodynamic therapy (PDT) in the treatment of denture stomatitis in complete denture wearers.

DRUGNystatin 100.000 units

Control group treated with nystatin

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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 treatmentthrough study completion, an average of 45 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026