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

Not Applicable

Completed

• Conditions: Vertical Fracture of Root of Tooth (Disorder)
• Interventions: Procedure: Endodontic Root Canal Treatment

• Registration Number: NCT05286073
• Lead Sponsor: Dow University of Health Sciences

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).

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-02-01
• Study First Submitted: 2022-02-04
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Hyflex EDm	Endodontic Root Canal Treatment	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).
F6 SkyTaper	Endodontic Root Canal Treatment	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).
One Shape	Endodontic Root Canal Treatment	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.

Primary Outcome Measures

Name	Time	Method
Vertical Root Fracture Resistance	5 minutes	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

Name	Time	Method
Crack pattern	2 minutes	crack pattern is complete/incomplete

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan