- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02867254
Candida Albicans in Periodontal and Endodontic Lesions in Diabetic and Normoglycemic Patients (diabetic)
Investigations of the Prevalence and Virulence of Candida Albicans in Periodontal and Endodontic Lesions in Diabetic and Normoglycemic Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This case-control study was conducted on thirty patients (15 patients with type 2 diabetes mellitus and 15 normoglycemics) with clinical and radiographic diagnosis of a periodontal endodontic lesion. To assess the glycemic control of the patients were measured the plasma glucose level and glycosylated hemoglobin concentrations (HbA1c). All patients were initially submitted to examination to verify the clinical periodontal parameters (plaque index, probing bleeding, probing depth, clinical attachment level and gingival recession) and pulp sensitivity testing. The study included patients who presented periodontal pockets involving the apical region of the tooth and pulp necrosis (periodontal endodontic lesion). Exclusion criteria were: use of antibiotics in the last six months, pregnancy, smoking, other systemic diseases, clinical signs of oral candidiasis, and patients who did not sign a free and clarified consent term.
Sample collection Collection from the root canal was performed after access, rubber dam isolation, disinfection of the surgical field with 5.25% sodium hypochlorite, and neutralization with 5% sodium thiosulfato, with 3 sterile paper points remaining in the root canal for one minute. Sampling of the periodontal pocket was made at the deepest site through 3 sterile paper points, inserted one by one for one minute. The material collected from the periodontal pocket and the root canal was inoculated in Eppendorf tubes containing 1 ml of reduced transport fluid (RTF). Next, samples from each site were diluted and plated on the medium Saboraund Dextrose Agar plus Chloramphenicol and chromogenic medium (CHROMagar Candida ®, BioMerieux, Paris, France) and incubated at 37° C for 48h in a reduced oxygen atmosphere (10% CO2 and 90% air). The green colonies that grew on CHROMagar plates were chosen at random and stored in glycerol at 20° C for later identification by PCR.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
-patients who presented periodontal pockets involving the apical region of the tooth and pulp necrosis (periodontal endodontic lesion).
Exclusion Criteria:
- use of antibiotics in the last six months,
- pregnancy,
- smoking,
- other systemic diseases,
- clinical signs of oral candidiasis
- patients who did not sign a free and clarified consent term.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Groups1
15 patients with type 2 diabetes mellitus with periodontal endodontic lesions
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Groups 2
15 non-diabetics with periodontal endodontic lesions
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sample collection from the root canal
Periodo de tiempo: 6 weeks
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Collection from the root canal was performed after access, rubber dam isolation, disinfection of the surgical field with 5.25% sodium hypochlorite, and neutralization with 5% sodium thiosulfato, with 3 sterile paper points remaining in the root canal for one minute.
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6 weeks
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Sample collection from the periodontal pocket
Periodo de tiempo: 6 weeks
|
Sampling of the periodontal pocket was made at the deepest site through 3 sterile paper points, inserted one by one for one minute.
The material collected from the periodontal pocket and the root canal was inoculated in Eppendorf tubes containing 1 ml of reduced transport fluid (RTF).
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Candida albicans
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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