Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05286073
Enrollment
88
Registered
2022-03-18
Start date
2019-02-01
Completion date
2022-02-01
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertical Fracture of Root of Tooth (Disorder)

Keywords

Hyflex EDM,F6 Sky Taper,One Shape

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).

Interventions

PROCEDUREEndodontic Root Canal Treatment

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).

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vertical Root Fracture Resistance5 minutesThe 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

MeasureTime frameDescription
Crack pattern2 minutescrack pattern is complete/incomplete

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026