- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07731594
Effectiveness of Three Different Irrigation Methods During a Root Canal Treatment
Effect of Various Irrigant Activation Methods and Its Penetration in the Apical Third of Root Canal
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study focuses on evaluating the effectiveness of three different root canal irrigation techniques in achieving irrigant penetration into the apical third of the root canal. Successful root canal treatment depends not only on mechanical instrumentation but also on adequate irrigation to eliminate bacteria, dissolve organic tissue, and remove debris from areas that instruments cannot reach. Due to the complex anatomy of the root canal system, studies have shown that nearly 35% of the canal walls remain untouched after instrumentation. Therefore, irrigation plays a vital role in ensuring complete disinfection of the canal system. Furthermore, bacteria are capable of penetrating 300-500 micrometers into the dentinal tubules, making it essential for the irrigant to reach as deep as possible within the canal.
Conventionally, sodium hypochlorite is delivered into the canal using a syringe and needle. Although it is considered the gold standard irrigant because of its tissue-dissolving ability and broad-spectrum antimicrobial action, conventional needle irrigation has limitations. The irrigant generally does not travel beyond the tip of the needle, leaving the apical third and other complex areas inadequately cleaned. To overcome these shortcomings, newer irrigation activation methods such as side-vented needles and ultrasonic irrigation have been introduced to improve irrigant flow and penetration throughout the root canal system.
The purpose of this study is to compare three irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), and Ultrasonic Irrigation (UI)-to determine which technique provides the deepest penetration of the irrigant into the apical third of the root canal. The hypothesis of the study is that ultrasonic irrigation, being an active irrigation technique, will result in significantly greater irrigant penetration than conventional needle irrigation and side-vented needle irrigation.
According to the synopsis, this study is designed as a randomized controlled trial and will be conducted in the Department of Operative Dentistry over a period of one year after approval. A total sample size of 105 teeth will be included, with 35 samples allocated to each of the three study groups. The study will include extracted single-rooted mandibular first and second premolars with straight canals and closed apices, while teeth with open apices, curved canals, or calcified canals will be excluded.
Initially, all selected teeth will be examined radiographically to exclude unsuitable samples. Standard access cavity preparation will then be carried out, followed by determination of the working length. The canals will be instrumented using the ProTaper rotary system up to file F3, while sodium hypochlorite will be used as the irrigating solution during instrumentation. After completion of canal preparation, the samples will be randomly assigned to one of the three irrigation groups: Conventional Needle Irrigation, Side-Vented Needle Irrigation, or Ultrasonic Irrigation.
To assess irrigant penetration, a radiopaque iohexol dye will be mixed with sodium hypochlorite. After irrigation using the assigned technique, digital radiographs will be obtained. The distance from the apical foramen to the deepest point reached by the radiopaque irrigant will be measured for each sample. This measurement will represent the depth of irrigant penetration achieved by each irrigation technique.
The collected data will be entered into Microsoft Excel and analyzed using SPSS version 23. Descriptive statistics, including the mean and standard deviation, will be calculated to compare the irrigant penetration among the three groups. Based on the study hypothesis, ultrasonic irrigation is expected to demonstrate the greatest penetration into the apical third of the root canal, suggesting that it may provide superior canal disinfection compared with conventional and side-vented needle irrigation. This expectation reflects the hypothesis stated in the synopsis rather than study results, as the research has not yet been conducted.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Haroon H Panezai, BDS
- Número de teléfono: +923128708722
- Correo electrónico: haroonhpanezai@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Straight Canals
- Single Rooted 1st and 2nd mandibular premolars with closed apices
Exclusion Criteria:
- Mandibular premolars with open apices
- Mandibular premolars with curved or calcified canals
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 |
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Comparador activo: Conventional Needle Irrigation
Participants in this group will receive root canal irrigation using a conventional 27-gauge syringe needle.
The irrigant, consisting of a radiopaque iohexol dye mixed with 5.25% sodium hypochlorite, will be delivered into the prepared root canal using the conventional needle irrigation technique.
Irrigant penetration into the apical third will be assessed using digital radiographs.
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Conventional syringe irrigation will be performed using a 27-gauge needle to deliver the radiopaque sodium hypochlorite solution into the prepared root canal.
No additional activation technique will be used during irrigation
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Comparador activo: Side Vented Needle Irrigation
Participants in this group will receive root canal irrigation using a side-vented irrigation needle.
The radiopaque irrigant solution, prepared by mixing iohexol dye with 5.25% sodium hypochlorite, will be delivered into the canal using the side-vented needle technique.
Irrigant penetration into the apical third will be measured on digital radiographs.
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Irrigation will be carried out using a side-vented needle to introduce the radiopaque sodium hypochlorite solution into the prepared canal.
The side-vented design is intended to improve irrigant distribution within the canal while minimizing direct apical flow
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Experimental: Ultrasonic Irrigation
Participants in this group will receive ultrasonic irrigation following completion of canal preparation.
A radiopaque irrigant solution consisting of iohexol dye mixed with 5.25% sodium hypochlorite will be ultrasonically activated within the root canal.
Digital radiographs will be used to measure the depth of irrigant penetration into the apical third and compare it with the other irrigation techniques
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Following canal preparation, the radiopaque sodium hypochlorite solution will be activated using an ultrasonic device to enhance irrigant movement throughout the root canal system before radiographic evaluation of penetration depth.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depth of irrigant penetration into the apical third of the root canal (measured in millimeters).
Periodo de tiempo: 5 months
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The primary outcome is the depth of penetration of a radiopaque irrigant solution into the apical third of the root canal following irrigation with Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), or Ultrasonic Irrigation (UI).
Penetration depth will be measured on digital radiographs as the distance from the apical foramen to the deepest point reached by the irrigant.
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5 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Haroon H Panezai, BDS, School Of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- SOD/ERB/2025/89
Plan de datos de participantes individuales (IPD)
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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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