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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04616469
• Other study ID #: ENDO:3-3-5 (8-10-2020)
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: Tarek Ali e mosalamy, MSc
• Phone: 01000089261
• Email: Tarek072501[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Root canal treatment using TruNaomy rotary files
Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system
• Root canal treatment using race rotary instruments
Race rotary files will be used for the process of cleaning and shaping of the root canal system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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