NCT05169879

Brief Summary

The aim of this clinical study is to evaluate the influence of early coronal flaring upon postoperative pain following root canal treatment in a single session approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

November 28, 2021

Last Update Submit

December 9, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (5)

  • postoperative pain

    The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

    after 4hours after treatment.

  • postoperative pain

    The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

    after 6hours after treatment.

  • postoperative pain

    The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

    after 12hours after treatment.

  • postoperative pain

    The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

    after 24hours after treatment.

  • postoperative pain

    The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

    after 48 hours after treatment.

Study Arms (2)

Early acoronal flaring

EXPERIMENTAL

In group A, ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length, then early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone

Procedure: coronal flaring

Non coronal flaring

ACTIVE COMPARATOR

In group B no coronal flaring will be performed following minimally invasive approach.

Procedure: Non coronal flaring

Interventions

coronal flaringPROCEDURE

early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone

Early acoronal flaring
Non coronal flaringPROCEDURE

No coronal flaring will be performed

Non coronal flaring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patient age above 18-70 years old.
  • \. Both males and females will be included.
  • \. All patients are in a good health without systemic condition.
  • \. The offending tooth is a molar.
  • \. The offending molar is indicated for root canal treatment.
  • \. One molar for every patient.
  • \. All patients will sign an informed consent.

You may not qualify if:

  • \. Necrotic molars
  • \. The offending tooth has previous attempt of pulp therapy or root canal treatment.
  • \. The patient showing any clinical or radiographic evidence of periapical pathosis.
  • \. Patients received analgesics or systemic antibiotic prior to treatment.
  • \. Immunocompromised patients.
  • \. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
  • \. History of cancer with radio or chemotherapy.
  • \. Offending molar with mobility score ≥2.
  • \. Offending molar with pocket depth ≥6mm.
  • \. Immature molars.
  • \. Nonodontogenic pain.
  • \. Patients with more than one tooth requiring endodontic intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (1)

  • Capar ID, Arslan H, Akcay M, Ertas H. An in vitro comparison of apically extruded debris and instrumentation times with ProTaper Universal, ProTaper Next, Twisted File Adaptive, and HyFlex instruments. J Endod. 2014 Oct;40(10):1638-41. doi: 10.1016/j.joen.2014.04.004. Epub 2014 May 27.

    PMID: 25260737BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Heba A ElAsfouri

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Heba A ElAsfouri

CONTACT

+201005276232heba.elasfouri@dentistry.cu.edu.eg

Mostafa I Negm

CONTACT

0122769110mostafaibrahim923@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 28, 2021

First Posted

December 27, 2021

Study Start

January 1, 2022

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)