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

3 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.
Experimental: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in root canal bacterial community profile
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Beatrix Zitzy Uniquen Enoch, DDS, Dental and Oral Hospital Hasanuddin University
  • Director de estudio: Prof. Maria Tanumihardja, DDS, MDS, Dental and Oral Hospital Hasanuddin University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de octubre de 2025

Finalización primaria (Actual)

30 de marzo de 2026

Finalización del estudio (Actual)

18 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

28 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

3 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 265/KEPK FKG-RSGMP UH/EA/IX/20

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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