Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

NCT ID: NCT02642900

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-07-31

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.

Conditions

Photochemotherapy Reaction

Keywords

Complete denture; Candida spp; Photodynamic therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Nystatin 100.000 units

Intervention Type: DRUG

Control group treated with nystatin

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).

Group Type: ACTIVE_COMPARATOR

Photodynamic Therapy

Intervention Type: PROCEDURE

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

Interventions

Photodynamic Therapy

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

Intervention Type: PROCEDURE

Nystatin 100.000 units

Control group treated with nystatin

Intervention Type: DRUG

Other Intervention Names

photochemotherapy; Nystatin

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Regina Tamaki

Professora Doutora

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Regina Tamaki, Profa. Dra.

Role: PRINCIPAL_INVESTIGATOR

Associated Professor

Locations

Faculdade de Odontologia da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DML01

Identifier Type: -

Identifier Source: org_study_id