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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07019792

Enrollment

120

Registered

2025-06-13

Start date

2024-10-01

Completion date

2025-07-31

Last updated

2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems, Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems

Keywords

post operative pain, Protaper Ultimate, Hyflex EDM, XP rsie, TruNatomy, Bacterial, Oval canal

Brief summary

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

Detailed description

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.

Interventions

OTHERProtaper ultimate

Using Protaper Ultimate file system for canal preperation

OTHERTruanatomy file system

Using Truanatomy file system for canal preperation

OTHERHyflex EDM

Using Hyflex file system for canal preperation

OTHERXp shaper rise

Using XPshaper rise system for canal preperation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	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
Bacterial count reduction	Sample will be collected before and directly after canal prepeartion	Bacterial count sample will be collected before and after canal prepeartion

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026