Clinical trial NCT04616469: Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation
Official title: Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:

* Post operative pain: incidence and intensity
* Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor
* Time needed for the instruments to reach to the full working length


Eligibility criteria: Inclusion Criteria:

* Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.
* Age between 30-60 years old.
* Males \& Females.
* Patients' acceptance for participating in the trial through an informed consent
* Maxillary permanent premolar teeth:

  * Diagnosed clinically and radiographically with pulp necrosis
  * With or without periapical radiolucency
  * Negative response of pulp tissue to thermal and electric pulp tester
  * Possessing two independent roots each having a type I canal
  * Patent canals with no internal calcification or resorptive lesions
  * Fully formed roots
  * Root curvatures less than 30

Exclusion Criteria:

* Patient with contributory medical condition
* Badly destructed teeth
* Patients with pre-operative pain
* Patients having significant systemic disorders
* Patients with two or more adjacent teeth requiring root canal therapy
* Patients who had received antibiotics in the last month
* Teeth presenting with:

  * Positive response to thermal or electric pulp tester
  * History of trauma or previous endodontic treatment
  * Immature or open apices
  * Association with acute periapical abscess and swelling or fistulous tract
  * Fused roots at any level
  * Canals larger than size 15# K-file
  * Periodontonal/ endodontic lesions
  * Mobility higher than grade I
  * Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
  * Severe root curvature (\>30)

Primary outcomes:
measure: Post operative pain using visual analogue scale
timeFrame: at 24 hours post treatment
measure: Post operative pain using visual analogue scale
timeFrame: at 48 hours post treatment
measure: Post operative pain using visual analogue scale
timeFrame: at 72 hours post treatment
measure: Post operative pain using visual analogue scale
timeFrame: at 1 week post treatment
Secondary outcomes:
measure: operative torque generated during instrumentation
timeFrame: during treatment
measure: time required for the instrument to reach the full working length
timeFrame: during treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
citation: Gambarini G, Galli M, Seracchiani M, Di Nardo D, Versiani MA, Piasecki L, Testarelli L. In Vivo Evaluation of Operative Torque Generated by Two Nickel-Titanium Rotary Instruments during Root Canal Preparation. Eur J Dent. 2019 Oct;13(4):556-562. doi: 10.1055/s-0039-1698369. Epub 2019 Dec 31.
citation: Zand V, Milani AS, Hassani Dehkharghani A, Rahbar M, Tehranchi P. Treatment of Necrotic Teeth Using Two Engine-Driven Systems and Patient's Postoperative Pain: A Double-Blind Clinical Trial. Iran Endod J. 2016 Fall;11(4):267-272. doi: 10.22037/iej.2016.3.