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

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Root canal treatment using TruNaomy rotary files
* Procedure: Root canal treatment using race rotary instruments


Participation Criteria
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Eligibility Criteria
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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 cold test (ethyl chloride) 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 cold test (ethyl chloride) 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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Root canal treatment using RaCe rotary system<br>Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity | Procedure: Root canal treatment using race rotary instruments<br>* Race rotary files will be used for the process of cleaning and shaping of the root canal system<br>|
| Experimental: Root canal treatment using TruNatomy rotary system<br>Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity | Procedure: Root canal treatment using TruNaomy rotary files<br>* Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain using visual analogue scale | pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible | at 24 hours post treatment | 
| Post operative pain using visual analogue scale | pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible | at 48 hours post treatment | 
| Post operative pain using visual analogue scale | pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible | at 72 hours post treatment | 
| Post operative pain using visual analogue scale | pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible | at 1 week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative torque generated during instrumentation | real time operative torque exerted on the instrument through out the shaping process and until the instrument reaches the full working length will be measured using a torque measuring motor in real time | during treatment | 
| time required for the instrument to reach the full working length | time required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor | during treatment |