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NCT Number: NCT07019792

Postoperative Pain and Bacterial Reduction in Oval Canals After Instrumentation With Different Noval Rotary Files Systems

Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruba Mustafa

Irbid, 21110, Jordan

About this study

One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically fit
  • Age ranges from 18-65 year
  • Restorable teeth
  • Necrotic teeth and symptoms free
  • Lower premolars teeth (single canal posterior teeth)
  • Necrotic pulps

Exclusion criteria

  • Medically compromised
  • Non-restorable teeth
  • Open apex canal
  • The past 12-hour history of analgesic intake before treatment.
  • Patients with a history of antibiotics intake in the last 3 months before treatment.
  • Pregnant females.
  • Symptomatic patient.
  • Pulpal diagnosis is not necrotic pulp.
  • Retreatment cases

Treatment and study plan

Protaper ultimate

Other

Using Protaper Ultimate file system for canal preperation

Truanatomy file system

Other

Using Truanatomy file system for canal preperation

Hyflex EDM

Other

Using Hyflex file system for canal preperation

Xp shaper rise

Other

Using XPshaper rise system for canal preperation

Primary outcomes

  1. Postoperative pain

    Time frame: at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment

    Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome.

    0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain

  2. Bacterial count reduction

    Time frame: Sample will be collected before and directly after canal prepeartion

    Bacterial count sample will be collected before and after canal prepeartion

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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