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

NCT ID: NCT07019792

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multifile system: Protaper Ultimate

Group Type EXPERIMENTAL

Protaper ultimate

Intervention Type OTHER

Using Protaper Ultimate file system for canal preperation

Multiple files systems:TruNatomy

Group Type EXPERIMENTAL

Truanatomy file system

Intervention Type OTHER

Using Truanatomy file system for canal preperation

Single file system: Hyflex EDM

Group Type EXPERIMENTAL

Hyflex EDM

Intervention Type OTHER

Using Hyflex file system for canal preperation

Single file system: Xp shaper rise

Group Type EXPERIMENTAL

Xp shaper rise

Intervention Type OTHER

Using XPshaper rise system for canal preperation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Protaper ultimate

Using Protaper Ultimate file system for canal preperation

Intervention Type OTHER

Truanatomy file system

Using Truanatomy file system for canal preperation

Intervention Type OTHER

Hyflex EDM

Using Hyflex file system for canal preperation

Intervention Type OTHER

Xp shaper rise

Using XPshaper rise system for canal preperation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jordan University of Science and Technology

OTHER

Sponsor Role collaborator

King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ruba Mustafa

Professor associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ruba Mustafa

Irbid, , Jordan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Jordan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20230408

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20230408

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.