- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07916987
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps: A Randomized Clinical Trial
he main objective of this study is to compare the impact of two different file motions-continuous rotation versus reciprocation-using the same endodontic file system (MG3 Blue rotary files) on postoperative pain and the amount of remaining bacteria inside the root canal in single-rooted teeth with necrotic pulps.
Extrusion of infected debris and persistent intracanal bacteria during root canal treatment can lead to postoperative pain and treatment complications. While various instrumentation systems have been evaluated, differences in file metallurgy, design, and number of files often obscure whether the observed outcomes are due to the movement (kinematics) or the file itself. This study aims to isolate the effect of motion kinematics by using identical rotary files in two distinct movement modes.
Participants will be randomly assigned to one of two groups:
Intervention Group (Reciprocation Motion): Canals will be prepared using MG3 Blue files operated in reciprocation motion.
Comparator Group (Continuous Rotation Motion): Canals will be prepared using MG3 Blue files operated in continuous rotation motion.
All procedures will be performed on single-rooted mandibular premolars diagnosed with pulp necrosis without apical periodontitis. Microbial samples will be collected before and after canal instrumentation to measure the reduction of cultivable bacteria (in colony-forming units, CFU/mL). Postoperative pain levels will be recorded by participants using a Visual Analogue Scale (VAS) at baseline, 24 hours, 48 hours, 72 hours, and 7 days after the first appointment.
The primary outcome of the study is post-instrumentation pain at 72 hours. Secondary outcomes include post-instrumentation pain at 7 days and the amount of remaining intracanal cultivable bacteria following canal preparation.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Background and RationaleA fundamental aim of root canal therapy is controlling pain and resolving apical periodontitis by thoroughly disinfecting the root canal system. Residual bacteria-particularly virulent species like Enterococcus faecalis-and their byproducts inside dentinal tubules are the leading cause of post-treatment complications and endodontic failure. During instrumentation, extruded infected debris can injure periapical tissues, triggering an inflammatory immune response and leading to postoperative pain and flare-ups. While previous research has evaluated how reciprocating versus continuous rotary systems affect postoperative pain and remaining bacteria, most studies used different file designs, cross-sections, or numbers of files, making it difficult to determine whether outcomes were driven by kinematics or file characteristics. This randomized clinical trial isolates the effect of motion kinematics by using identical MG3 Blue rotary files under two different motion dynamics. Study ObjectivesTo compare the effect of different kinematics (continuous rotation versus reciprocation) using MG3 Blue rotary files on:The intensity of postoperative pain. The amount of remaining intracanal cultivable bacteria. Trial DesignType: Parallel, single-center, randomized controlled trial (superiority framework). Allocation Ratio: 1:1. Setting: Post-graduate outpatient clinic of the Endodontics Department, Faculty of Dentistry, Cairo University, Egypt. Participants and Eligibility CriteriaInclusion Criteria:Patients aged between 18 and 50 years (males and females). Systemically healthy (ASA I or II) with no history of anti-inflammatory or antibiotic medications in the past month. Mandibular premolars presenting with a single canal and non-vital pulps (negative response to ethyl chloride cold test, absence of spontaneous pain, and no apical periodontitis). Patients capable of understanding the pain scale and signing the informed consent. Exclusion Criteria:Medically compromised patients (ASA III or IV), pregnant females, or teeth with swelling, fistulous tracts, acute/chronic periapical abscesses, grade II/III mobility, previous root canal therapy, non-restorable structure, or open/immature apices. Intervention Procedures & Protocol StepsPreoperative Evaluation: Medical/dental history collection and baseline pain assessment using a Modified Visual Analogue Scale (VAS). Local Anesthesia & Disinfection: Local anesthesia administration followed by disinfection of the oral cavity using 0.2% chlorhexidine gluconate mouthwash and rubber dam isolation. Access Cavity & Working Length: Access cavity preparation, followed by patency confirmation using stainless steel K-files (#10 and #15). Working length is determined via an electronic apex locator and verified radiographically to be 1 mm shorter than the radiographic apex. Pre-instrumentation Sampling (S1): Initial intracanal microbiological samples are collected using sterile paper points retained for 60 seconds (placed in LAL water for endotoxin assay and VMGA III transport medium for microbial cultivation). Randomized Mechanical Preparation: Patients are allocated via computer-generated randomization to one of two groups: Intervention Group (Reciprocation Motion): Canals are prepared using MG3 Blue rotary files in reciprocation motion (#20/0.10, #15/0.03, #20/0.04, #25/0.04, #30/0.04, and #35/0.04 at 300 RPM and 2 Ncm torque). Comparator Group (Continuous Rotation Motion): Canals are prepared using the same MG3 Blue rotary files in continuous rotation motion following manufacturer instructions (same sizes, 300 RPM, and 2 Ncm torque). Irrigation Protocol: Canals are thoroughly irrigated between file sizes using 3 mL of 2.25% sodium hypochlorite via a 27-gauge side-vented needle, finalized with a saline wash. Post-instrumentation Sampling (S2): Second microbial sample collected identically to S1. Canals are dried, temporarily sealed, and patients are scheduled for a 7-day follow-up appointment for root canal obturation via warm vertical compaction. Outcomes and AssessmentPrimary Outcome: Post-instrumentation pain measured at 72 hours post-procedure using the Visual Analogue Scale (VAS ranging from 0 to 10). Secondary Outcomes:Post-instrumentation pain measured at 7 days post-procedure. Amount of remaining intracanal cultivable bacteria measured via microbiological culture techniques in colony-forming units (CFU/mL) pre- and post-instrumentation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed G Farahat, Assist. Lecturer of Endodontic
- Número de teléfono: +20 1151444452
- Correo electrónico: mohamed-farahat@dentistry.cu.edu.eg
Ubicaciones de estudio
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Cairo Governorate
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Cairo, Cairo Governorate, Egipto, 11251
- Cairo University
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Contacto:
- Mohamed G Farahat, Assist. Lecturer of Endodontic
- Número de teléfono: +20 1151444452
- Correo electrónico: mohamed-farahat@dentistry.cu.edu.eg
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Investigador principal:
- Mohamed G Farahat, Assist Lecturer of Enndodontic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age between 18-50 years.
- Males/Females.
- Mandibular premolars:
- Single canal.
- Non-Vital pulps.
- Negative response to cold pulp tester (ethyl chloride spray1).
- Absence of spontaneous pain.
- Absence of apical periodontitis.
- Systemically healthy patients (ASA I or II)
- No anti-inflammatory or antibiotic medications taken in the past month
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria:
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- Teeth with swelling or fistulous tract.
- Teeth with acute or chronic periapical abscess.
- Mobility Grade II or III.
- Previous root canal therapy.
- Non-restorable teeth.
- Immature teeth
- Pregnant females.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: MG3 Blue rotary file - Reciprocation
MG3 Blue rotary file utilized in reciprocation motion |
MG3 blue rotary files utilized in reciprocation motion |
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Comparador activo: MG3 Blue rotary file - Continuous rotation
MG3 blue rotary file utilized in continuous rotation motion |
MG3 Blue rotary files utilized in continuous rotation motion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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post operative pain
Periodo de tiempo: 72 hours post instrumentation, 7 days post instrumentation
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Visual Analogue Scale |
72 hours post instrumentation, 7 days post instrumentation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intracanal bacterial reduction
Periodo de tiempo: Sample 1 before instrumentation, Sample 2 immediately after instrumentation
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Microbiological Culture Technique. Sample 1 will be collected from canals after access cavity preparation and Sample 2 will be collected right after mechanical preparation of the canals. |
Sample 1 before instrumentation, Sample 2 immediately after instrumentation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Alaa Diab, Professor of Endodontics, Cairo University
- Director de estudio: Sarah Samir, Associate professor, Cairo University
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
- New Endo 3-3-3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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