- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Groups1
15 patients with type 2 diabetes mellitus with periodontal endodontic lesions
|
Groups 2
15 non-diabetics with periodontal endodontic lesions
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Sample collection from the root canal
Délai: 6 weeks
|
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.
|
6 weeks
|
Sample collection from the periodontal pocket
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- Candida albicans
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .