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Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hydroxide Medicament in Root Canal Treatment (BactProfil-RCT)

3 juin 2026 mis à jour par: Beatrix Zitzy Uniquen Enoch, Hasanuddin University

Bacterial Profile Changes During Root Canal Treatment With 5.25% and 3% Sodium Hypochlorite Irrigation and Calcium Hydroxide Medicament Assessed by 16S rRNA PCR

The goal of this clinical trial is to learn how the bacterial profile in infected root canals changes during different phases of routine root canal treatment in adults with chronic apical abscess. The main questions it aims to answer are:

  • How does the root canal bacterial profile change before and after irrigation with 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite?
  • How does the bacterial profile change after calcium hydroxide medicament is placed in the root canal?

Participants will:

  • Receive standard root canal treatment with one of two irrigation regimens (5.25 percent or 3 percent sodium hypochlorite, plus EDTA),
  • Have root canal samples taken three times (before any treatment, after irrigation, and after calcium hydroxide medicament), and
  • Have the bacteria in these samples analyzed using 16S rRNA PCR and DNA sequencing.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Chronic apical abscess is associated with complex multispecies biofilms in the root canal that can differ between populations and are not fully characterized by conventional culture methods. This study focuses on adult patients with necrotic molar teeth and chronic apical abscess treated at the Dental and Oral Hospital, Faculty of Dentistry, Hasanuddin University. The main objective is to describe how the root canal bacterial community profile changes during different phases of routine root canal treatment using 16S rRNA PCR and sequence analysis.

The study uses a descriptive and analytic repeated-measures design. At least 24 adult outpatients with necrotic pulp and chronic apical abscess who meet the inclusion and exclusion criteria will be recruited and provide written informed consent. After rubber dam isolation, access cavity preparation, and working length determination, the first root canal sample (S1) is collected from the distal canal using a sterile Hedström file and transferred into a tube containing DNA preservative solution. Mechanical preparation is then performed with rotary instruments. Patients are randomly assigned by clinic staff, who are blinded to the investigator, to one of two irrigation regimens: 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite, each followed by sterile distilled water, 17 percent EDTA, and a final rinse with sterile distilled water. A second sample (S2) is collected from the same canal after irrigation. Calcium hydroxide intracanal medicament is then placed and the tooth is temporized.

After approximately two weeks, the temporary restoration and calcium hydroxide are removed, and a third sample (S3) is collected from the same canal using a sterile Hedström file. All samples are stored in DNA preservative solution and analyzed by 16S rRNA PCR followed by DNA sequencing to characterize the bacterial community composition and diversity. The study will compare bacterial taxa and community profiles at S1, S2, and S3 and between the two sodium hypochlorite concentrations in order to explore how root canal irrigation and calcium hydroxide medicament are associated with changes in the bacterial community.

Type d'étude

Interventionnel

Inscription (Réel)

24

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Indonésie
    • South Sulawesi
      • Makassar, South Sulawesi, Indonésie, 90245
        • Dental and Oral Hospital Hasanuddin University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adult aged between 18 and 75 years.
  • Physically and mentally able to undergo treatment
  • Have not used antibiotics within 1 week before treatment.
  • Permanent molar teeth showing clinical and radiographic signs of chronic apical abscess and considered restorable.
  • Willing to participate in the study and able to provide written informed consent after receiving an explanation of the study.

Exclusion Criteria:

  • Systemic conditions that require antibiotic prophylaxis for routine dental treatment or other significant systemic disease.
  • Pregnant or breastfeeding women.
  • Participants with cognitive impairment.
  • Teeth with advanced mobility (greater than grade 2).
  • Teeth with periodontal pockets deeper than 4 mm.
  • Teeth with radiographic signs of root resorption.
  • Teeth with calcification or obliteration of the root canal.
  • Teeth with root fracture or that fracture during treatment.
  • Teeth with open apices.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 5.25% sodium hypochlorite Irrigation
Participants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 5.25 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament.
Procédure: Root canal treatment with 5.25% sodium hypochlorite irrigation
Standard root canal procedure in which the canal is irrigated with 5.25 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points.
Expérimental: 3% sodium hypochloritel Irrigation
Participants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 3 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament.
Procédure: Root canal treatment with 3% sodium hypochlorite irrigation
Standard root canal procedure in which the canal is irrigated with 3 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in root canal bacterial community profile
Délai: Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).
Bacterial community composition and diversity in root canal samples from molar teeth with chronic apical abscess, assessed using 16S rRNA PCR and DNA sequencing at three time points (before treatment, after irrigation, and after calcium hydroxide medicament).
Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hasanuddin University

Les enquêteurs

  • Chercheur principal: Beatrix Zitzy Uniquen Enoch, DDS, Dental and Oral Hospital Hasanuddin University
  • Directeur d'études: Prof. Maria Tanumihardja, DDS, MDS, Dental and Oral Hospital Hasanuddin University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 octobre 2025

Achèvement primaire (Réel)

30 mars 2026

Achèvement de l'étude (Réel)

18 mai 2026

Dates d'inscription aux études

Première soumission

28 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 265/KEPK FKG-RSGMP UH/EA/IX/20

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared because of privacy considerations and institutional and ethics committee policies that restrict sharing of identifiable clinical data outside the study team.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

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