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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Vertical Fracture of Root of Tooth (Disorder)

Intervention / Treatment
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* Procedure: Endodontic Root Canal Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyflex EDm<br>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). | Procedure: Endodontic Root Canal Treatment<br>* 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).<br>|
| Experimental: F6 SkyTaper<br>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). | Procedure: Endodontic Root Canal Treatment<br>* 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).<br>|
| Experimental: One Shape<br>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. | Procedure: Endodontic Root Canal Treatment<br>* 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).<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crack pattern | crack pattern is complete/incomplete | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyflex EDM,F6 Sky Taper,One Shape