Clinical trial NCT05286073: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vertical Fracture of Root of Tooth (Disorder)
Keywords: Hyflex EDM,F6 Sky Taper,One Shape
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 88
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Vertical Root Fracture Resistance
timeFrame: 5 minutes
Secondary outcomes:
measure: Crack pattern
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Farah Naz, BDS,FCPS
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.