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Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files

Primary Purpose

Vertical Fracture of Root of Tooth (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Endodontic Root Canal Treatment
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vertical Fracture of Root of Tooth (Disorder) focused on measuring Hyflex EDM,F6 Sky Taper,One Shape

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Extracted Human mandibular premolar canals that fulfill the following criteria were used.

    • permanent teeth
    • intact and fully formed apices
    • straight and single rooted canal
    • roots having similar diameter mesiodistally(2-4mm) and buccolingually(4-6mm)

Exclusion Criteria:

  • Roots having following features were excluded;

    • root caries
    • roots with multiple canals
    • previous root canal treatment done
    • signs of calcification, internal and external root resorption
    • cracks
    • fracture lines
    • C-shaped canals
    • Vertical Root Fracture

Sites / Locations

  • Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Hyflex EDm

F6 SkyTaper

One Shape

Control

Arm Description

The canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm).

The canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm).

Canals were prepared and shaped with single rotational file system One Shape with the sequence of Endoflare (12, 0.12), One G (18, 0.03) and One Shape (12.06) connected to endodontic motor with rotational speed of 400rpm and 4 Ncm torque as recommended by manufacturer.

In the control group, no endodontic instrumentation and shaping was done in the canals. Only the necrotic pulp tissue was extirpated from the canals with the help of barbed broaches and then the specimens were analyzed for fracture testing.

Outcomes

Primary Outcome Measures

Vertical Root Fracture Resistance
The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine one at a time. 0.5 mm diameter round tip stainless-steel rod was fixed to the upper stage of the universal testing machine (Instron, Canton, MA, USA). The rod was centered over the canal orifice of each root. The universal testing machine (Instron) was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, at a rate of 1.0 mm per min, until the root fractured. This point was verified by the computer monitoring the Instron testing machine; at the same time the crack was heard, the monitor showed a sharp drop in force. The test was terminated at this point and the force applied was recorded. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).

Secondary Outcome Measures

Crack pattern
crack pattern is complete/incomplete

Full Information

First Posted
February 4, 2022
Last Updated
March 17, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05286073
Brief Title
Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files
Official Title
Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

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 purpose of this study is the assessment of vertical root fracture resistance of roots prepared with three different single endodontic rotary files in extracted human mandibular premolar roots.
Detailed Description
88 human extracted mandibular premolars will be selected. Teeth will be sectioned below cementoenamel junction to get 13mm from the apex of root. Roots will then be standardized according to buccolingual and mesiodistal widths and will be examined for fracture and craze lines. The roots will then be randomly divided into 3 experimental groups and 1 control group (n=22). Group 1 will be instrumented with Hyflex EDM. Group 2 will be instrumented with F6 Sky Taper. Group 3 will be instrumented with One Shape and Group 4 will be negative control group in which no instrumentation will be done. After performing rotary instrumentation, roots will then be obturated with respective GP and sealer. Samples will then be exposed to vertical load utilizing Universal Testing Machine till fracture occur which will be recorded in Newton(N).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertical Fracture of Root of Tooth (Disorder)
Keywords
Hyflex EDM,F6 Sky Taper,One Shape

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Samples were randomly divided in 4 groups. Random sampling was done with computer generated method. There were 3 working groups comprising of 22 canals and 1 negative control group having 22 canals.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyflex EDm
Arm Type
Experimental
Arm Description
The canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm).
Arm Title
F6 SkyTaper
Arm Type
Experimental
Arm Description
The canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm).
Arm Title
One Shape
Arm Type
Experimental
Arm Description
Canals were prepared and shaped with single rotational file system One Shape with the sequence of Endoflare (12, 0.12), One G (18, 0.03) and One Shape (12.06) connected to endodontic motor with rotational speed of 400rpm and 4 Ncm torque as recommended by manufacturer.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, no endodontic instrumentation and shaping was done in the canals. Only the necrotic pulp tissue was extirpated from the canals with the help of barbed broaches and then the specimens were analyzed for fracture testing.
Intervention Type
Procedure
Intervention Name(s)
Endodontic Root Canal Treatment
Intervention Description
Root canal shaping procedures were performed. Irrigation was done after each three pecks of endodontic file. After instrumentation (Groups 1-3), the canals were dried with sterile paper points. The dentinal walls were then coated with Sealapex. For vertical root fracture resistance testing, sample preparation was done in acrylic blocks. Then roots were coated with polyvinylsiloxane impression material. After that roots were inserted again into acrylic resin blocks. The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine. 0.5 mm diameter round tip stainless-steel rod was fixed to the universal testing machine. The universal testing machine was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, until the root fractured. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).
Primary Outcome Measure Information:
Title
Vertical Root Fracture Resistance
Description
The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine one at a time. 0.5 mm diameter round tip stainless-steel rod was fixed to the upper stage of the universal testing machine (Instron, Canton, MA, USA). The rod was centered over the canal orifice of each root. The universal testing machine (Instron) was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, at a rate of 1.0 mm per min, until the root fractured. This point was verified by the computer monitoring the Instron testing machine; at the same time the crack was heard, the monitor showed a sharp drop in force. The test was terminated at this point and the force applied was recorded. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Crack pattern
Description
crack pattern is complete/incomplete
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Extracted Human mandibular premolar canals that fulfill the following criteria were used. permanent teeth intact and fully formed apices straight and single rooted canal roots having similar diameter mesiodistally(2-4mm) and buccolingually(4-6mm) Exclusion Criteria: Roots having following features were excluded; root caries roots with multiple canals previous root canal treatment done signs of calcification, internal and external root resorption cracks fracture lines C-shaped canals Vertical Root Fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farah Naz, BDS,FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29628648
Citation
Pawar AM, Pawar MG, Thakur B, Banga KS, Luke AM. Resistance to fracture of teeth instrumented using novel EndoStar E5 rotary versus ProTaper NEXT and WaveOne file systems. J Conserv Dent. 2018 Jan-Feb;21(1):52-56. doi: 10.4103/JCD.JCD_216_16.
Results Reference
background
PubMed Identifier
27099419
Citation
Pawar AM, Barfiwala D, Pawar M, Metzger Z, Kfir A, Jain N. Assessment of the fracture resistance of teeth instrumented using 2 rotary and 2 reciprocating files versus the Self-Adjusting File (SAF): An ex vivo comparative study on mandibular premolars. J Conserv Dent. 2016 Mar-Apr;19(2):138-42. doi: 10.4103/0972-0707.178692.
Results Reference
background
PubMed Identifier
24666910
Citation
Capar ID, Altunsoy M, Arslan H, Ertas H, Aydinbelge HA. Fracture strength of roots instrumented with self-adjusting file and the ProTaper rotary systems. J Endod. 2014 Apr;40(4):551-4. doi: 10.1016/j.joen.2013.08.030. Epub 2013 Oct 15.
Results Reference
background
PubMed Identifier
26106635
Citation
Tavanafar S, Karimpour A, Karimpour H, Mohammed Saleh A, Hamed Saeed M. Effect of Different Instrumentation Techniques on Vertical Root Fracture Resistance of Endodontically Treated Teeth. J Dent (Shiraz). 2015 Mar;16(1 Suppl):50-5.
Results Reference
background

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Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files

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