Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation
NCT ID: NCT04616469
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2023-05-01
2024-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial
NCT04862702
3D Instrumentation Versus Rotary Instrumentation
NCT03285334
Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment
NCT06777381
Postoperative Pain Assessment After Using Different Kinematics
NCT04277520
Pain Intensity After Root Canal Instrumentation
NCT04216940
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Root canal treatment using RaCe rotary system
Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity
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
Root canal treatment using TruNatomy rotary system
Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
30 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tarek Ali El Mosalamy
Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Al-Mosalmy TA, El-Far HM, Gomaa MM, Morsy DA. Impact of root canal shaping using TruNatomy on postoperative pain and operative torque generation: a randomized clinical trial. BMC Oral Health. 2025 Jul 19;25(1):1222. doi: 10.1186/s12903-025-06418-z.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ENDO:3-3-5 (8-10-2020)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.