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AzTrials

Necrotic Pulps With no Apical PeriodontitisNCT07916987

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 study testing Engine driven files utilized in reciprocation motion and engine driven rotary files utilized in continuous rotation motion in people with Necrotic Pulps With no Apical Periodontitis, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Engine driven files utilized in reciprocation motion and engine driven rotary files utilized in continuous rotation motion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteEgypt
Study dates
1 Nov 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18-50 years.
  • Males/Females.
  • Mandibular premolars:
  • Single canal.
  • Non-Vital pulps.
  • Negative response to cold pulp tester (ethyl chloride spray1).
Show all 12Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed G Farahat, Assist. Lecturer of Endodontic contact

1151444452 ext. +20

mohamed-farahat@dentistry.cu.edu.eg

Egypt1 site
  • Cairo University

    Cairo, Cairo Governorate, 11251

    Mohamed G Farahat, Assist. Lecturer of Endodontic, 1151444452 ext. +20, mohamed-farahat@dentistry.cu.edu.eg

    Mohamed G Farahat, Assist Lecturer of Enndodontic

Other trials in Egypt

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Engine driven files utilized in reciprocation motion, engine driven rotary files utilized in continuous rotation motion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Engine driven files utilized in reciprocation motionDevice

    MG3 blue rotary files utilized in reciprocation motion

  • engine driven rotary files utilized in continuous rotation motionDevice

    MG3 Blue rotary files utilized in continuous rotation motion

Study groups in NCT07916987
Study groupRoleWhat they receive
MG3 Blue rotary file - ReciprocationExperimentalMG3 Blue rotary file utilized in reciprocation motion
Receives: Device: Engine driven files utilized in reciprocation motion
MG3 Blue rotary file - Continuous rotationActive comparatorMG3 blue rotary file utilized in continuous rotation motion
Receives: Device: engine driven rotary files utilized in continuous rotation motion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. post operative pain

    Visual Analogue Scale

    Measured: 72 hours post instrumentation, 7 days post instrumentation

Secondary outcomes (1)
  1. Intracanal bacterial reduction

    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.

    Measured: Sample 1 before instrumentation, Sample 2 immediately after instrumentation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trail
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916987
Sponsor's protocol ID
New Endo 3-3-3
Status last verified
Oct 2026
First submitted
18 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Engine driven files utilized in reciprocation motion and engine driven rotary files utilized in continuous rotation motion in people with Necrotic Pulps With no Apical Periodontitis, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed G Farahat, Assist. Lecturer of Endodontic (1151444452 ext. +20, mohamed-farahat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post operative pain (time frame: 72 hours post instrumentation, 7 days post instrumentation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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