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Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases (RCT)

10 de junio de 2026 actualizado por: Ain Shams University

Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial

The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications:

  1. Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite
  2. Calcium Silicate
  3. Calcium Hydroxide

In retreatment cases in terms of:

  1. Biological Evaluation: Biomarker (IL 1B)
  2. Radiographic Evaluation: CBCT
  3. Clinical Evaluation: Pain Score (VAS)

Descripción general del estudio

Descripción detallada

Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 1

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.

Estudio Contacto

Ubicaciones de estudio

      • Cairo, Egipto
        • Reclutamiento
        • Ain Shams University
        • Contacto:
          • Ain Shams University
          • Número de teléfono: 00201000397491

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

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

  1. Age: 21-45 years.
  2. Medically free patients. (ASA Class 1)
  3. Gender: males and females
  4. Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
  5. Restorable root canal treated permanent lower first molars with periapical lesions.
  6. Small (<5 mm) or medium periapical lesion size (5-10 mm)

Exclusion Criteria:

  1. Patients with a history of allergic reactions to any of the study materials.
  2. Teeth that become non-restorable after complete caries excavation.
  3. Teeth that have mobility or deep periodontal pockets.
  4. Teeth with internal or external resorption.

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Calcium Silicate Intracanal Medication
Calcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus)
Calcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing. Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility.
Experimental: Calcium Hydroxide Slurry mixed with Sodium Hypochlorite
Calcium Hydroxide slurry mixed with 3% Sodium Hypochlorite
Combining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed. NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action. Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols.
Comparador activo: Calcium Hydroxide
Calcium Hydroxide Intracanal Medication (Control Group)
Calcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation. It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect. Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resistant microorganisms such as Candida Albicans and Enterococcus Faecalis.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Biological Evaluation of inflammatory marker (IL-1B)
Periodo de tiempo: 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.
IL-1B collected by periapical fluid sample using paper points and measured using ELISA.
1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Radiographic Evaluation using limited FOV CBCT
Periodo de tiempo: 1 year between pre- and post-operative CBCT scans.
Pre-operative and post-operative limited FOV CBCT scans are taken to compare volumetric reduction in periapical lesion size.
1 year between pre- and post-operative CBCT scans.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Evaluation using Pain Score (Visual Analogue Scale)
Periodo de tiempo: Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals
evaluation of pain score using Visual Analogue Scale on a scale of 0-10 with 0 representing no pain and 10 representing the most severe pain (subjective)
Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals

Colaboradores e Investigadores

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

Patrocinador

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)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de junio de 2026

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

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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

producto fabricado y exportado desde los 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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