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

D

Dow University of Health Sciences

Status

Completed

Conditions

Vertical Fracture of Root of Tooth (Disorder)

Treatments

Procedure: Endodontic Root Canal Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05286073
IRB-1658/DUHS/Approval/2020/

Details and patient eligibility

About

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.

Full 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).

Enrollment

88 patients

Sex

All

Ages

25 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

88 participants in 4 patient groups

Hyflex EDm
Experimental group
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).
Treatment:
Procedure: Endodontic Root Canal Treatment
F6 SkyTaper
Experimental group
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).
Treatment:
Procedure: Endodontic Root Canal Treatment
One Shape
Experimental group
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.
Treatment:
Procedure: Endodontic Root Canal Treatment
Control
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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