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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.

28 ottobre 2026 aggiornato da: Mohamed Farahat, Cairo University

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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Cairo Governorate
      • Cairo, Cairo Governorate, Egitto, 11251
        • Cairo University
        • Contatto:
        • Investigatore principale:
          • Mohamed G Farahat, Assist Lecturer of Enndodontic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MG3 Blue rotary file - Reciprocation

MG3 Blue rotary file utilized in reciprocation motion

MG3 blue rotary files utilized in reciprocation motion

Comparatore attivo: MG3 Blue rotary file - Continuous rotation

MG3 blue rotary file utilized in continuous rotation motion

MG3 Blue rotary files utilized in continuous rotation motion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
post operative pain
Lasso di tempo: 72 hours post instrumentation, 7 days post instrumentation

Visual Analogue Scale

72 hours post instrumentation, 7 days post instrumentation

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intracanal bacterial reduction
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Alaa Diab, Professor of Endodontics, Cairo University
  • Direttore dello studio: Sarah Samir, Associate professor, Cairo University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

18 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • New Endo 3-3-3

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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