- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07671326
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide-Based Intracanal Medicaments in Endodontic Treatment
Descripción general del estudio
Estado
Descripción detallada
This randomized controlled clinical trial investigates the effect of two different intracanal medicaments on the reduction of intracanal bacterial load in mandibular molar teeth diagnosed with chronic apical periodontitis. The study is conducted at Istanbul Medipol University Faculty of Dentistry, Department of Endodontics, and includes systemically healthy participants aged 18-65 years who require primary root canal treatment and present with radiographic evidence of periapical radiolucency.
Participants are randomly assigned to two groups. In the first group, Bio-C Temp is used as the intracanal medicament. In the second group, a UltraCal XS is applied. All teeth are isolated with a rubber dam, and the operative field is disinfected before access cavity preparation. After removal of previous restorations and caries, sterility control samples are collected from the tooth surface.
Working length is determined using an electronic apex locator and confirmed radiographically. Initial microbiological samples are collected from the root canals using sterile paper points. Root canal shaping is performed with heat-treated nickel-titanium rotary files, and canal enlargement is completed with a VDW Rotate #35/.04 file. The irrigation protocol includes 2.5% sodium hypochlorite and 17% EDTA, followed by passive ultrasonic irrigation using an IRRI S ultrasonic tip. Sodium hypochlorite is inactivated with 10% sodium thiosulfate before microbiological sampling.
After chemomechanical preparation, the assigned intracanal medicament is placed 1-2 mm short of the working length, and the access cavity is temporarily sealed. Participants are recalled after 14 days. At the second appointment, the intracanal medicament is removed mechanically and chemically. A neutralization step is performed before further sampling, and the final irrigation and ultrasonic activation protocol is repeated.
Bacterial samples are collected at different stages of treatment, including baseline, after chemomechanical preparation, after medicament removal, and after final irrigation. The bacterial load is quantified using droplet digital PCR, a sensitive molecular method that allows absolute quantification of bacterial DNA. This technique is used to compare the antibacterial effect of Bio-C Temp and calcium hydroxide and to evaluate bacterial reduction throughout the treatment protocol.
Pain levels are also recorded using a visual analog scale. After completion of the sampling and irrigation procedures, the root canals are obturated with gutta-percha using the lateral condensation technique, and the access cavities are restored with composite resin. A final periapical radiograph is taken for treatment control.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34230
- Reclutamiento
- Istanbul Medipol University
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Contacto:
- Berke Turgut
- Número de teléfono: +905312267156
- Correo electrónico: dtberketurgut@gmail.com
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Contacto:
- Tan Fırat Eyüboğlu
- Número de teléfono: +905304636059
- Correo electrónico: tfeyuboglu@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged between 18 and 65 years
- Being systemically healthy (ASA I or ASA II)
- Mandibular molar teeth with a radiographically detectable radiolucent lesion in the periapical region
- Willingness of the volunteer or their legal representative to participate in the study by signing the Informed Consent Form
Exclusion Criteria:
- Patients who have received antibiotics or corticosteroids within the last 3 months
- Patients with systemic diseases
- Teeth that cannot be properly isolated with a rubber dam
- Teeth with periodontal pockets >4 mm and teeth with crown/root fractures
- Individuals who are undergoing or planning to start orthodontic treatment during the study period
- Pregnant or breastfeeding individuals
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament
Intervention: Participants in this group receive Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, after standardized chemomechanical root canal preparation and passive ultrasonic irrigation.
The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days.
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Participants in this group undergo root canal shaping using VDW Rotate heat-treated nickel-titanium rotary files, and root canal preparation is completed up to #35/.04.
The irrigation protocol includes 2.5% sodium hypochlorite (NaOCl) and 17% EDTA, followed by passive ultrasonic irrigation (PUI) using a VDW Ultra device with an IRRI S 21/25 ultrasonic tip.
After chemomechanical preparation and microbiological sampling, Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, is placed into the root canals 1-2 mm short of the working length.
The access cavity is temporarily sealed, and the medicament is left in place for 14 days.
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Comparador activo: UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament
Intervention: Participants in this group receive UltraCal XS, a calcium hydroxide-based intracanal medicament, after the same standardized chemomechanical root canal preparation and passive ultrasonic irrigation protocol.
The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days.
|
Participants in this group undergo the same standardized root canal shaping and irrigation protocol as the Bio-C Temp group.
Root canal shaping is performed using VDW Rotate heat-treated nickel-titanium rotary files and completed up to #35/.04.
The irrigation protocol includes 2.5% sodium hypochlorite (NaOCl), 17% EDTA, and passive ultrasonic irrigation (PUI) with a VDW Ultra device and an IRRI S 21/25 ultrasonic tip.
After chemomechanical preparation and microbiological sampling, UltraCal XS, a calcium hydroxide-based intracanal medicament, is placed into the root canals 1-2 mm short of the working length.
The access cavity is temporarily sealed, and the medicament is left in place for 14 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reduction in Intracanal Bacterial Load
Periodo de tiempo: From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.
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Quantitative reduction in intracanal bacterial load in mandibular molar teeth with chronic apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following standardized chemomechanical root canal preparation, passive ultrasonic irrigation, and the application of two different intracanal medicaments.
Bacterial samples are collected at predetermined stages of treatment to compare the antibacterial effectiveness of Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, and UltraCal XS, a calcium hydroxide-based intracanal medicament.
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From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10840098-202.3.02-2258
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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.
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