An interventional study of ProTaper Manual Root Canal Instrumentation and ProTaper Rotary Root Canal Instrumentation in Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis and Postoperative Pain After Endodontic Treatment, sponsored by College of Physicians and Surgeons Pakistan. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by College of Physicians and Surgeons Pakistan · Not applicable, Interventional, and Treatment
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
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
College of Physicians and Surgeons Pakistan is the lead sponsor of 15 studies on the registry; 12 are open to participants now.
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Patients with a single tooth diagnosed with symptomatic irreversible pulpitis with or without symptomatic apical periodontitis
Teeth with a single canal and good radiographically apical morphology suitable for standardized instrumentation with both ProTaper Manual and ProTaper Rotary file systems
Teeth that have a correct working length and a standardised study protocol for the treatment of the root canal system
Patients who are able and willing to take the pain assessments at the scheduled times throughout the specified follow-up time period
Exclusion Criteria:
Patients taking analgesics, anti-inflammatory drugs, corticosteroids, or other medications that may affect pain or inflammation
Teeth with acute swelling, cellulitis, or acute apical abscess
Teeth with advanced periodontal disease or excessive mobility
Previously root canal-treated teeth or teeth requiring retreatment
Teeth with root resorption, perforation, immature apices, or structural abnormalities affecting standardized treatment
Participants in this arm will receive root canal instrumentation using ProTaper Manual nickel-titanium hand files (SX, S1, S2, F1, F2, F3) with a defined crown-down technique according to the manufacturer's recommended sequence. The ProTaper Manual system is a hand-operated nickel-titanium instrumentation system consisting of a straight set of shaping and finishing files with a progressively tapered convex triangular cross-section, used to mechanically prepare the root canal by manual instrumentation. All other aspects of treatment (access cavity preparation, working length determination, irrigation protocol, obturation, and restoration) will be identical to Group B.
Procedure: ProTaper Manual Root Canal Instrumentation · Procedure: ProTaper Rotary Root Canal Instrumentation
Participants in this arm will receive root canal instrumentation using ProTaper Rotary nickel-titanium files (SX, S1, S2, F1, F2, F3) using an endodontic motor at manufacturer-recommended speed and torque settings. The ProTaper Rotary system is an engine-driven nickel-titanium instrumentation system with continuously rotated, progressively tapered, convex triangular cross-section (shaping and finishing files) used to mechanically prepare the root canal using a progressive rotary motion provided by an endodontic motor. All other aspects of treatment (access cavity preparation, working length determination, irrigation protocol, obturation, and restoration) will be identical to Group A
Procedure: ProTaper Manual Root Canal Instrumentation · Procedure: ProTaper Rotary 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.
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.
Postoperative Pain Intensity (Visual Analogue Scale)
Postoperative pain intensity measured using a 10 cm Visual Analogue Scale (VAS) where 0 = no pain and 10 = worst possible pain. Patients will record pain scores in a diary at 6, 12, 24, 48, and 72 hours, and 7 days after root canal instrumentation. The primary outcome is the comparison of postoperative pain scores between the ProTaper Manual and ProTaper Rotary groups at each assessment interval.
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours, and 7 days postoperatively
Incidence of Postoperative Pain
Proportion of patients reporting any postoperative pain (VAS \> 0) at each assessment interval. This will be expressed as a percentage and compared between the ProTaper Manual and ProTaper Rotary groups.
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours, and 7 days postoperatively
No study locations are listed for this record.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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College of Physicians and Surgeons Pakistan