Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses (CAM-AAA)
Comparative Evaluation of the Antibacterial Efficacy of Calcium Hydroxide and a Calcium Silicate-Based Intracanal Medicament in Teeth With Acute Apical Abscesses Using Real-Time PCR: A Randomized Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Acute apical abscess is an endodontic infection characterized by localized inflammation, pain, swelling, and purulent exudate. Although chemomechanical root canal preparation substantially reduces the bacterial load, microorganisms may remain within the root canal system. Intracanal medicaments are therefore used between treatment sessions to improve microbial reduction.
In this randomized, parallel-group clinical trial, teeth diagnosed with acute apical abscess are allocated to receive either a calcium hydroxide intracanal medicament or a calcium silicate-based intracanal medicament. All teeth undergo standardized root canal treatment and irrigation procedures.
Microbiological samples are collected at three main treatment stages: before chemomechanical preparation, after chemomechanical preparation and irrigation, and after a 7- to 10-day intracanal medication period. Bacterial DNA is analyzed using SYBR Green Real-Time PCR. Universal 16S rRNA primers are used to quantify the total bacterial load. Selected bacterial species associated with endodontic infections are also evaluated.
The primary outcome is the change in total bacterial load between the post-instrumentation sample and the sample collected after intracanal medication. Secondary outcomes include changes in selected bacterial species and bacterial levels across the different sampling stages. The study aims to determine and compare the microbial effectiveness of the two intracanal medicaments in acute apical abscess cases.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Erzurum
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Erzurum, Erzurum, Turquie (Türkiye), 25240
- Recrutement
- Ataturk University Faculty of Dentistry
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Contact:
- Halit Aladağ, DDS, PhD
- Numéro de téléphone: +905414675965
- E-mail: haladag@atauni.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Diagnosis of acute apical abscess
- A single-rooted permanent tooth requiring primary endodontic treatment
- Age between 18 and 65 years
- No history of systemic disease
- American Society of Anesthesiologists physical status classification I (ASA I)
- Provision of written informed consent
Exclusion Criteria:
- Previous endodontic treatment of the affected tooth
- Periodontal probing depth greater than 4 mm
- History of trauma involving the affected tooth
- Pregnancy or breastfeeding
- Immunodeficiency
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Calcium Hydroxide Group
After standardized chemomechanical root canal preparation, a calcium hydroxide-based intracanal medicament is placed into the root canal to 1 mm short of the working length and remains in the canal for 7 to 10 days.
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Calcium hydroxide-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.
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Expérimental: Calcium Silicate-Based Medicament Group
After standardized chemomechanical root canal preparation, a calcium silicate-based intracanal medicament is placed into the root canal to 1 mm short of the working length and remains in the canal for 7 to 10 days.
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Calcium silicate-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Total Bacterial Load After Intracanal Medication
Délai: From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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Total bacterial load will be quantified using universal 16S rRNA gene-based Real-Time PCR in samples collected after chemomechanical root canal preparation (S2) and after the 7- to 10-day intracanal medication period (S3).
The antibacterial effect will be evaluated as the change in log10 bacterial load from S2 to S3 and compared between the two intervention groups.
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From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in the Levels of Selected Endodontic Bacterial Species
Délai: From before chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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The levels of Fusobacterium nucleatum, Prevotella intermedia, Porphyromonas endodontalis, Parvimonas micra, Treponema denticola, Streptococcus anginosus, Dialister pneumosintes, Campylobacter rectus, Filifactor alocis, and Olsenella uli will be evaluated using species-specific Real-Time PCR.
Changes between the samples collected before chemomechanical preparation (S1), after chemomechanical preparation (S2), and after intracanal medication (S3) will be assessed and compared between the intervention groups.
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From before chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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Change in Total Bacterial Load After Chemomechanical Preparation
Délai: From before to immediately after chemomechanical root canal preparation during the first treatment visit
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Total bacterial load will be quantified using universal 16S rRNA gene-based Real-Time PCR in samples collected before chemomechanical root canal preparation (S1) and immediately after chemomechanical preparation (S2).
The change in log10 bacterial load from S1 to S2 will be evaluated to determine the bacterial reduction achieved by the standardized chemomechanical preparation protocol.
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From before to immediately after chemomechanical root canal preparation during the first treatment visit
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- ATAUNI-ENDO-AAA-01
- 16653 (Autre subvention/numéro de financement: Atatürk University Scientific Research Projects Coordination Unit)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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