Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Procedure: Root canal treatment using TruNaomy rotary files; Procedure: Root canal treatment using race rotary instruments

Study type: Interventional

Funder types: Other

Identifiers

NCT04616469

ENDO:3-3-5 (8-10-2020)

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Root canal treatment using RaCe rotary system

Active Comparator group

Description:

Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity

Treatment:

Procedure: Root canal treatment using race rotary instruments

Root canal treatment using TruNatomy rotary system

Experimental group

Description:

Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity

Treatment:

Procedure: Root canal treatment using TruNaomy rotary files