Public trial
RBR-4rq6jrk Photodynamic therapy as an aid in the treatment of oral candidiasis in patients admitted to the intensive care unit
Date of registration: 05/04/2026 (mm/dd/yyyy)Last approval date : 05/04/2026 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Antimicrobial photodynamic therapy as an adjunctive treatment for oral candidiasis in patients hospitalized in the intensive care unit: a randomized clinical trial
pt-br
Terapia fotodinâmica antimicrobiana como tratamento coadjuvante da candidose oral em pacientes internados em unidade de terapia intensiva:ensaio clínico randomizado
es
Antimicrobial photodynamic therapy as an adjunctive treatment for oral candidiasis in patients hospitalized in the intensive care unit: a randomized clinical trial
Trial identification
- UTN code: U1111-1333-4277
-
Public title:
en
Photodynamic therapy as an aid in the treatment of oral candidiasis in patients admitted to the intensive care unit
pt-br
Terapia fotodinâmica como ajuda no tratamento da candidose oral em pacientes internados na unidade de terapia intensiva
-
Scientific acronym:
-
Public acronym:
-
Secondaries identifiers:
-
90445525.1.0000.5537
Issuing authority: Plataforma Brasil
-
7.896.537
Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Rio Grande do Norte
-
90445525.1.0000.5537
Sponsors
- Primary sponsor: Departamento de Odontologia
-
Secondary sponsor:
- Institution: Hospital Giselda Trigueiro
-
Supporting source:
- Institution: Departamento de Odontologia
Health conditions
-
Health conditions:
en
oral,candidiasis
pt-br
candidiase bucal
-
General descriptors for health conditions:
en
C01.150.703.160 Candidiasis
pt-br
C01.150.703.160 Candidíase
-
Specific descriptors:
en
C01.150.703.160.180 Candidiasis,Oral
pt-br
C01.150.703.160.180 Candidíase Bucal
Interventions
-
Interventions:
en
The study is a randomized controlled clinical trial. Randomization will be performed in blocks, with no blinding. The control group, consisting of 15 participants, will receive the conventional oral hygiene protocol performed once daily, associated with antifungal treatment using oral nystatin solution at a dose of 100000 IU and intravenous fluconazole, both administered for seven consecutive days. The experimental group, consisting of 15 participants, will undergo the same oral hygiene protocol and intravenous fluconazole as the control group, with the addition of two sessions of antimicrobial photodynamic therapy performed at intervals of 72 hours. All 30 participants will be evaluated at three time points, baseline, 72 hours, and 7 days, with exfoliative cytology collected at all evaluation times
pt-br
O estudo é um ensaio clínico controlado e randomizado, à randomização será realizada em blocos, sem cegamento. O Grupo controle com 15 participantes, receberá o protocolo convencional de higiene bucal realizado uma vez ao dia, associado ao tratamento antifúngico com nistatina solução oral 100.000 UI e fluconazol intravenoso ambos administrados por sete dias consecutivos; O grupo experimental, com 15 participantes, será submetido ao mesmo protocolo referente à higiene bucal e fluconazol intravenoso como no controle, com a adição de duas sessões de TFDa com intervalo de 72h; os 30 participantes serão analisados nos 3 tempos, inicial, 72 hrs e 7 dias; em todos esses tempos sendo coletada a citologia esfoliativa
-
Descriptors:
en
E02.186.500 Photochemotherapy
pt-br
E02.186.500 Fotoquimioterapia
Recruitment
- Study status: Recruitment completed
-
Countries
- Brazil
- Date first enrollment: 11/10/2025 (mm/dd/yyyy)
-
Target sample size: Gender: Minimum age: Maximum age: 30 - 18 Y 0 -
Inclusion criteria:
en
Patients with a clinical diagnosis of oral candidiasis admitted to the intensive care unit of the study site;Patients aged 18 years or older men and women;Patients who have been hospitalized in the intensive care unit for a minimum period of 48 hours
pt-br
Pacientes com diagnóstico clínico de candidose oral internados na unidade de terapia intensiva do local de estudo; Pacientes maiores de 18 anos homens ou mulheres;Pacientes que apresentem um período mínimo de 48 horas de internação na unidade de terapia intensiva
-
Exclusion criteria:
en
Pregnant and breastfeeding women;Patients whose mouth opening is insufficient to allow proper intraoral clinical examination as well as the procedures required for antimicrobial photodynamic therapy;Patients with invasive candidiasis and candidemia
pt-br
Mulheres grávidas e lactantes;Pacientes cuja abertura bucal seja insuficiente para a realização do exame clínico intrabucal adequado bem como para as etapas da terapia fotodinâmica antimicrobiana;Pacientes com candidose invasiva e candidemia
Study type
-
Study design:
-
Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 2 N/A Randomized-controlled 2
Outcomes
-
Primary outcomes:
en
It is expected that the experimental group will present cure rates similar to or higher than those of the control group in the treatment of oral candidiasis at the end of seven days.
pt-br
Espera-se encontrar que o grupo experimental tenha taxa de cura semelhantes ou superiores no tratamento de candidose oral, quando comparado com o grupo controle ao fim dos 7 dias
-
Secondary outcomes:
en
It is expected that patients who do not achieve clinical cure at the end of seven days will present a reduction in the number of affected sites and in the extent of the infection.
pt-br
Espera-se que nos pacientes que ao fim dos 7 dias não tiverem atingido a cura clínica tenha diminuição dos sítios e da extensão da infecção
Contacts
-
Public contact
- Full name: Éricka Janine Dantas da Silveira
-
- Address: Avenida Senador Salgado Filho
- City: Natal / Brazil
- Zip code: 59056-000
- Phone: +55(84)3215-4138
- Email: ericka_janine@yahoo.com.br
- Affiliation: Universidade Federal Do Rio Grande Do Norte (UFRN)- Departamento de odontologia
-
Scientific contact
- Full name: Éricka Janine Dantas da Silveira
-
- Address: Avenida Senador Salgado Filho
- City: Natal / Brazil
- Zip code: 59056-000
- Phone: +55(84)3215-4138
- Email: ericka_janine@yahoo.com.br
- Affiliation: Universidade Federal Do Rio Grande Do Norte (UFRN)- Departamento de odontologia
-
Site contact
- Full name: Éricka Janine Dantas da Silveira
-
- Address: Avenida Senador Salgado Filho
- City: Natal / Brazil
- Zip code: 59056-000
- Phone: +55(84)3215-4138
- Email: ericka_janine@yahoo.com.br
- Affiliation: Universidade Federal Do Rio Grande Do Norte (UFRN)- Departamento de odontologia
Additional links:
Total de Ensaios Clínicos 18139.
Existem 9169 ensaios clínicos registrados.
Existem 5004 ensaios clínicos recrutando.
Existem 133 ensaios clínicos em análise.
Existem 6055 ensaios clínicos em rascunho.