Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

NCT02642900 | Completed Phase 4 DMC

• 1 other identifier: DML01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Photochemotherapy Reaction

Keywords

Complete denture; Candida spp; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nystatin 100.000 units

EXPERIMENTAL

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

Photodynamic Therapy

ACTIVE COMPARATOR

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

Interventions

Photodynamic Therapy PROCEDURE

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

Also known as: photochemotherapy

Photodynamic Therapy

Nystatin 100.000 units DRUG

Control group treated with nystatin

Also known as: Nystatin

Nystatin 100.000 units

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculdade de Odontologia da Universidade de São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Interventions

Photochemotherapy; Nystatin

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Macrolides; Lactones; Organic Chemicals

Study Officials

• Regina Tamaki, Profa. Dra.

  Associated Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professora Doutora

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: December 30, 2015
• Study Start: July 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

BR (1)