NCT07019792

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

May 27, 2025

Last Update Submit

June 12, 2025

Conditions

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

Keywords

post operative painProtaper UltimateHyflex EDMXP rsieTruNatomyBacterialOval canal

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    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

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

  • Bacterial count reduction

    Bacterial count sample will be collected before and after canal prepeartion

    Sample will be collected before and directly after canal prepeartion

Study Arms (4)

Multifile system: Protaper Ultimate

EXPERIMENTAL
Other: Protaper ultimate

Multiple files systems:TruNatomy

EXPERIMENTAL
Other: Truanatomy file system

Single file system: Hyflex EDM

EXPERIMENTAL
Other: Hyflex EDM

Single file system: Xp shaper rise

EXPERIMENTAL
Other: Xp shaper rise

Interventions

Protaper ultimateOTHER

Using Protaper Ultimate file system for canal preperation

Multifile system: Protaper Ultimate
Truanatomy file systemOTHER

Using Truanatomy file system for canal preperation

Multiple files systems:TruNatomy
Hyflex EDMOTHER

Using Hyflex file system for canal preperation

Single file system: Hyflex EDM
Xp shaper riseOTHER

Using XPshaper rise system for canal preperation

Single file system: Xp shaper rise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruba Mustafa

Irbid, 21110, Jordan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor associate

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 13, 2025

Study Start

October 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)