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Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Sponsor: College of Physicians and Surgeons Pakistan
Summary
This randomized controlled trial aims to compare postoperative pain after root canal treatment using two different types of ProTaper file systems: manual (hand-held) and rotary (engine-driven). A total of 186 participants aged 18-60 years with symptomatic irreversible pulpitis (with or without symptomatic apical periodontitis) requiring primary root canal treatment on a single tooth will be enrolled. Participants will be randomly assigned to one of two groups: Group A will receive root canal instrumentation using ProTaper Manual files, and Group B will receive instrumentation using ProTaper Rotary files. Both groups will undergo a standardized single-visit root canal treatment protocol. Postoperative pain will be assessed using a Visual Analogue Scale (VAS) at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours, and 7 days after treatment. The study hypothesis is that there is no statistically significant difference in postoperative pain between the two instrumentation techniques. The findings will help clinicians choose the most appropriate instrumentation technique to minimize patient discomfort and improve treatment satisfaction
Official title: Comparative Evaluation of Postoperative Pain Following Root Canal Instrumentation Using ProTaper Manual and ProTaper Rotary File Systems: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-12-05
Completion Date
2027-06-05
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
ProTaper Manual Root Canal Instrumentation
Mechanical preparation of the root canal using ProTaper Manual nickel-titanium hand files (SX, S1, S2, F1, F2, F3) with a progressively tapered convex triangular cross-section. The instrumentation will be performed using a defined crown-down technique according to the manufacturer's recommended sequence. The ProTaper Manual system is a hand-operated nickel-titanium instrumentation system used to mechanically prepare the root canal by manual instrumentation.
ProTaper Rotary Root Canal Instrumentation
Mechanical preparation of the root canal using ProTaper Rotary nickel-titanium files (SX, S1, S2, F1, F2, F3) with a progressively tapered convex triangular cross-section. The instrumentation will be performed using an endodontic motor at manufacturer-recommended speed and torque settings. The ProTaper Rotary system is an engine-driven nickel-titanium instrumentation system used to mechanically prepare the root canal using a progressive rotary motion.