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

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
coronal flaring
Non coronal flaring
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early acoronal flaring

Non coronal flaring

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 28, 2021
Last Updated
December 9, 2021
Sponsor
Cairo University
Collaborators
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05169879
Brief Title
Influence of Early Coronal Flaring Upon Postoperative Pain After Root Canal Treatment
Acronym
flaring
Official Title
Influence of Early Coronal Flaring Upon Postoperative Pain Following Root Canal Treatment. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early acoronal flaring
Arm Type
Experimental
Arm Description
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
Arm Title
Non coronal flaring
Arm Type
Active Comparator
Arm Description
In group B no coronal flaring will be performed following minimally invasive approach.
Intervention Type
Procedure
Intervention Name(s)
coronal flaring
Intervention Description
early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone
Intervention Type
Procedure
Intervention Name(s)
Non coronal flaring
Intervention Description
No coronal flaring will be performed
Primary Outcome Measure Information:
Title
postoperative pain
Description
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Time Frame
after 4hours after treatment.
Title
postoperative pain
Description
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Time Frame
after 6hours after treatment.
Title
postoperative pain
Description
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Time Frame
after 12hours after treatment.
Title
postoperative pain
Description
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Time Frame
after 24hours after treatment.
Title
postoperative pain
Description
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Time Frame
after 48 hours after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A ElAsfouri
Phone
+201005276232
Email
heba.elasfouri@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa I Negm
Phone
0122769110
Email
mostafaibrahim923@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba A ElAsfouri
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University Faculty of Dentistry
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25260737
Citation
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.
Results Reference
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Influence of Early Coronal Flaring Upon Postoperative Pain After Root Canal Treatment

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