Comparison of Post-Operative Pain With and Without Apical Patency in Asymptomatic Irreversible Pu… (NCT07648862) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Post-Operative Pain With and Without Apical Patency in Asymptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Pakistan150 participantsStarted 2025-06-01
Plain-language summary
This study compares post-operative pain in teeth with asymptomatic irreversible pulpitis treated with versus without apical patency during root canal treatment.
Asymptomatic irreversible pulpitis is a condition where the dental pulp is inflamed but the patient does not feel spontaneous pain. Apical patency is a technique where a small flexible file is passed gently beyond the tip of the tooth root during cleaning and shaping.
One hundred fifty patients with premolar teeth diagnosed with asymptomatic irreversible pulpitis were randomly assigned to one of two groups. The Apical Patency Group received root canal treatment with a #10 K-file passed 0.5 mm beyond the working length after each rotary instrument. The Non-Patency Group received the same treatment but no instrument was passed beyond the working length.
The primary outcome is pain incidence at 24 hours measured on a Numerical Rating Scale (0 to 10, where 0 is no pain and 10 is worst pain imaginable). Secondary outcomes include pain intensity at 6,12,24,48,72 hours, number of ibuprofen tablets taken for pain, and time until pain completely resolves.
The study aims to determine whether the apical patency technique reduces post-operative pain compared to standard treatment without patency.
Who can participate
Age range
20 Years – 50 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:
* \- Age 20 to 50 years
* American Society of Anesthesiologists Physical Status I or II
* Maxillary or mandibular first or second premolar requiring non-surgical root canal treatment
* Confirmed asymptomatic irreversible pulpitis (deep caries, prolonged cold test response ≥10 seconds, no spontaneous pain, no periapical radiolucency)
* Written informed consent obtained
Exclusion Criteria:
* \- Uncontrolled diabetes (HbA1c \>7%) or uncontrolled hypertension
* Chronic pain syndromes or immunosuppression
* Analgesic/corticosteroid/antidepressant use within 2 weeks
* Immature apex, root resorption, root fracture, or curvature \>30 degrees
* Calcified canals, pocket depth \>4 mm, mobility \>Grade I, or non-restorable crown
* Retreatment cases or inability to achieve anesthesia
* Pregnancy
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
Pain Incidence at 24 Hours
Timeframe: 24 hours after completion of root canal treatment
Trial details
NCT IDNCT07648862
SponsorBolan Medical Complex Hospital Quetta Pakistan