- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mohamed G Farahat, Assist. Lecturer of Endodontic
- Numéro de téléphone: +20 1151444452
- E-mail: mohamed-farahat@dentistry.cu.edu.eg
Lieux d'étude
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Cairo Governorate
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Cairo, Cairo Governorate, Egypte, 11251
- Cairo University
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Contact:
- Mohamed G Farahat, Assist. Lecturer of Endodontic
- Numéro de téléphone: +20 1151444452
- E-mail: mohamed-farahat@dentistry.cu.edu.eg
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Chercheur principal:
- Mohamed G Farahat, Assist Lecturer of Enndodontic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: MG3 Blue rotary file - Reciprocation
MG3 Blue rotary file utilized in reciprocation motion |
MG3 blue rotary files utilized in reciprocation motion |
|
Comparateur actif: MG3 Blue rotary file - Continuous rotation
MG3 blue rotary file utilized in continuous rotation motion |
MG3 Blue rotary files utilized in continuous rotation motion |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
post operative pain
Délai: 72 hours post instrumentation, 7 days post instrumentation
|
Visual Analogue Scale |
72 hours post instrumentation, 7 days post instrumentation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intracanal bacterial reduction
Délai: Sample 1 before instrumentation, Sample 2 immediately after instrumentation
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Alaa Diab, Professor of Endodontics, Cairo University
- Directeur d'études: Sarah Samir, Associate professor, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- New Endo 3-3-3
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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