Comparison of WaveOne and ProTaper Systems on Postoperative Pain in Irreversible Pulpitis Patients (NCT07510490) | Clinical Trial Compass
CompletedNot Applicable
Comparison of WaveOne and ProTaper Systems on Postoperative Pain in Irreversible Pulpitis Patients
Pakistan146 participantsStarted 2025-08-11
Plain-language summary
This study aims to compare two commonly used root canal instrumentation systems, WaveOne (reciprocating system) and ProTaper (rotary system), in patients diagnosed with symptomatic irreversible pulpitis. Root canal treatment is performed to remove inflamed pulp tissue, disinfect the canal, and relieve pain. However, some patients experience pain after the procedure, particularly within the first few days.
In this randomized controlled trial, 146 patients will be assigned to receive root canal treatment using either WaveOne or ProTaper instruments. All procedures will be performed under standardized clinical conditions by a single operator. Patients will be asked to record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals after treatment, including 6, 12, 24, 48, and 72 hours, and at one week.
The purpose of this study is to determine whether one instrumentation system results in less postoperative pain compared to the other. The findings may help improve patient comfort and guide dentists in selecting the most appropriate root canal instrumentation technique.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients aged 18-60 years Patients diagnosed with symptomatic irreversible pulpitis Patients requiring root canal treatment in permanent teeth Teeth with canal curvature ≤25° (assessed using Schneider's method) Patients willing to provide informed consent
Exclusion Criteria:
Patients with systemic illness Pregnant patients Patients with hypersensitivity to nonsteroidal anti-inflammatory drugs Teeth with apical pathology or periapical lesions Teeth with root resorption or internal ankylosis History of dental trauma in the affected tooth Teeth with malposition or severe malocclusion Patients with periodontal disease (periodontal index \<3) Patients with trismus or sinus tract Patients with severe anxiety affecting dental procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intensity of Postoperative Pain Following Root Canal Instrumentation
Timeframe: 6, 12, 24, 48, and 72 hours after instrumentation, and at 1 week
Trial details
NCT IDNCT07510490
SponsorArmed Forces Institute of Dentistry, Pakistan