flaring: Influence of Early Coronal Flaring Upon Postoperative Pain After Root Canal Treatment

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05169879

Collaborator

Zagazig University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: coronal flaring Procedure: Non coronal flaring	N/A

Detailed Description

All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur.

Canals will be scouted using manual patency file in a watch winding maneuver. 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. In group B no coronal flaring will be performed following minimally invasive approach.

Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device.

Canals will be irrigated again with 10ml 1.5% NaOCl, which will be delivered 2mm coronal to apical canal terminus. Irrigation will be hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using yellow tips #15/02 inserted 2mm short of working length for 60 seconds. ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland) till # X3 (Elnaghy et al. 2014). Each file will be used in one molar. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Influence of Early Coronal Flaring Upon Postoperative Pain Following Root Canal Treatment. A Randomized Clinical Trial

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early acoronal flaring 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 early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone
Active Comparator: Non coronal flaring In group B no coronal flaring will be performed following minimally invasive approach.	Procedure: Non coronal flaring No coronal flaring will be performed

Arm

Intervention/Treatment

Experimental: Early acoronal flaring

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

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

Active Comparator: Non coronal flaring

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

Procedure: Non coronal flaring

No coronal flaring will be performed

Outcome Measures

Primary Outcome Measures

postoperative pain [after 4hours after treatment.]
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain [after 6hours after treatment.]
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain [after 12hours after treatment.]
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain [after 24hours after treatment.]
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain [after 48 hours after treatment.]
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Faculty of Dentistry	Cairo		Egypt

Sponsors and Collaborators

Cairo University
Zagazig University

Investigators

Study Director: Heba A ElAsfouri, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Heba Elasfouri, Associate professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05169879

Other Study ID Numbers:

Endo 28-11-2021

First Posted:

Dec 27, 2021

Last Update Posted:

Dec 27, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Dec 27, 2021