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

NCT ID: NCT05169879

Last Updated: 2021-12-27

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

coronal flaring

Intervention Type PROCEDURE

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

Non coronal flaring

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

Group Type ACTIVE_COMPARATOR

Non coronal flaring

Intervention Type PROCEDURE

No coronal flaring will be performed

Interventions

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coronal flaring

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

Intervention Type PROCEDURE

Non coronal flaring

No coronal flaring will be performed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Patient age above 18-70 years old.

* 2\. Both males and females will be included.
* 3\. All patients are in a good health without systemic condition.
* 4\. The offending tooth is a molar.
* 5\. The offending molar is indicated for root canal treatment.
* 6\. One molar for every patient.
* 7\. All patients will sign an informed consent.

Exclusion Criteria

* 1\. Necrotic molars

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Heba Elasfouri

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba A ElAsfouri

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University Faculty of Dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Heba A ElAsfouri

Role: CONTACT

Phone: +201005276232

Email: [email protected]

Mostafa I Negm

Role: CONTACT

Phone: 0122769110

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 25260737 (View on PubMed)

Other Identifiers

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Endo 28-11-2021

Identifier Type: -

Identifier Source: org_study_id