- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07623278
Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hydroxide Medicament in Root Canal Treatment (BactProfil-RCT)
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
Estado
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
South Sulawesi
-
Makassar, South Sulawesi, Indonesia, 90245
- Dental and Oral Hospital Hasanuddin University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
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
¿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
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
Publicaciones Generales
- Siqueira JF Jr, Rocas IN. Present status and future directions: Microbiology of endodontic infections. Int Endod J. 2022 May;55 Suppl 3:512-530. doi: 10.1111/iej.13677. Epub 2022 Jan 13.
- Wang, X., et al. (2023). Longitudinal Analysis of Root Canal Microbiome Using 16S rRNA Sequencing. Journal of Endodontics.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 265/KEPK FKG-RSGMP UH/EA/IX/20
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
Ensayos clínicos sobre Infección del conducto radicular
-
Sonendo, Inc.Terminado
-
Shiraz University of Medical SciencesDesconocido
-
Sara Reda Abdelhamid AboseifCairo UniversityTerminado
-
Cairo UniversityAún no reclutandoBloque del canal aductor
-
Ain Shams UniversityAún no reclutando
-
Women's College HospitalTerminadoAnestesia | Bloque del canal aductorCanadá
-
Cairo UniversityAún no reclutandoRadix Entomolaris | Canal Medio Mesial
-
Ankara Etlik City HospitalAún no reclutandoAnatomía | Bloque del canal aductorTurquía (Türkiye)
-
Assiut UniversityAún no reclutandoMedición del canal espinal lumbar