Comparative Evaluation of Postoperative Pain and Clinical Success (NCT07133217) | Clinical Trial Compass
CompletedNot Applicable
Comparative Evaluation of Postoperative Pain and Clinical Success
Turkey (Türkiye)63 participantsStarted 2024-06-11
Plain-language summary
Sixty-three mandibular molars with vital pulp, symptomatic acute pain, and a Numerical Rating Scale (NRS) score of 7 or higher-requiring emergency treatment-were randomly allocated into three groups according to the preparation systems to be used: conventional manual instrumentation technique with hand files, reciprocating motion technique with WaveOne Gold files, and rotary motion technique with ProTaper Ultimate files.
In the first session, patients received emergency treatment with one of the three file systems, and seven days later, root canal treatments were completed using the same system within each patient group. Preoperative pain scores of patients presenting to our clinic with acute pain were recorded using the Numerical Rating Scale (NRS).
During the emergency root canal treatment session, the first group was instrumented with hand files, the second group with WaveOne Gold files, and the third group with ProTaper Ultimate files, and the emergency treatment session was completed. Shaping times were measured during the procedures.
Following the emergency session, patients were instructed to record their postoperative pain at the 6th hour, 12th hour, and on the 1st, 2nd, 3rd, 4th, 5th, 6th, and 7th days using the provided NRS.
One week after the emergency treatment session, root canal obturation was performed using each system's own gutta-percha and Bioceramic root canal sealer. Clinical and radiographic follow-ups were carried out at 6 and 12 months.
Who can participate
Age range
18 Years – 65 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 18-65
* Patients who can come to regular check-ups and have high treatment motivation
* Patients who can establish an appropriate patient-doctor dialogue
* Patients without systemic disease
* Patients with teeth that have not previously undergone endodontic treatment
* Patients who meet the clinical definition of symptomatic irreversible pulpitis (pain, prolonged sensitivity to hot and cold,percussion sensitivity, pulpal bleeding)
* Delayed positive response of teeth to cold testing and electric pulp testing
* Presence of spontaneous pain before treatment
* Mandibular first or second molar with complete root development
* Formation of large pulpal perforation during caries removing
* Presence of bleeding in the exposed pulp that cannot be stopped within 5 minutes after the pulp exposure
Exclusion Criteria:
* Patients who refused to participate in the study
* Patients at medical risk (patients with immune system diseases/systemic diseases, patients using medication),
* Patients with NSAID (non-steroidal anti-inflammatory) allergy
* Patients with allergy to the materials used during root canal treatment
* Patients who used antibiotics or analgesics before applying to the clinic
* Pregnant patients
* Asymptomatic or devital teeth
* Presence of advanced periodontal disease (probing depth\> 3 mm)
* Patients with more than one tooth requiring endodontic treatment
* The relevant tooth has previously undergone endodontic treatment
* The tooth ne…
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
The incidence and intensity of post-obturation pain