Symptomatic Irreversible Pulpitis (SIP)NCT07887087
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
A study testing ProTaper Manual Root Canal Instrumentation and ProTaper Rotary Root Canal Instrumentation in people with Symptomatic Irreversible Pulpitis (SIP) and Symptomatic Apical Periodontitis, run by College of Physicians and Surgeons Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis, Postoperative Pain After Endodontic Treatment
- What is being tested?
- ProTaper Manual Root Canal Instrumentation and ProTaper Rotary Root Canal Instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2026to 5 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-60 years requiring primary root canal treatment
- 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
Who cannot join
- Patients with significant systemic or medical conditions that may affect pain perception, inflammatory response, or endodontic treatment
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation of Postoperative Pain Following Root Canal Instrumentation Using ProTaper Manual and ProTaper Rotary File Systems: A Randomized Controlled Trial
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
Read the detailed description
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
- Conditions
- Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis, Postoperative Pain After Endodontic Treatment
- Being tested
- ProTaper Manual Root Canal Instrumentation, ProTaper Rotary Root Canal Instrumentation
- Keywords
- ProTaper, Manual Instrumentation, Rotary Instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTaper Manual Root Canal InstrumentationProcedure or surgery
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 InstrumentationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ProTaper Manual | Experimental | 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. Receives: Procedure: ProTaper Manual Root Canal Instrumentation; Procedure: ProTaper Rotary Root Canal Instrumentation |
| ProTaper Rotary | Active comparator | 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 Receives: Procedure: ProTaper Manual Root Canal Instrumentation; Procedure: ProTaper Rotary Root Canal Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours, and 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start5 Dec 2026 (estimated)
- Primary completion5 May 2027 (estimated)
- Study completion5 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiz ur rahman, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887087
- Sponsor's protocol ID
- KCD-OD-2025-001
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hajwel M, Elemam R, Elsewify T, Eid B. Effect of ProTaper Ultimate and ProTaper Gold on Postoperative Pain in Mandibular First Molars With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Control Clinical Trial. Pain Res Manag. 2025 Oct 30;2025:9718875. doi: 10.1155/prm/9718875. eCollection 2025.
PubMed 41211526