Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis (NCT07375576) | Clinical Trial Compass
RecruitingNot Applicable
Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis
Turkey (Türkiye)99 participantsStarted 2025-12-01
Plain-language summary
The aim of this study is to evaluate the clinical effectiveness of total pulpotomy (TP), radicular pulpotomy (RP), and root canal treatment (RCT) in mandibular premolar and/or molar teeth diagnosed with symptomatic irreversible pulpitis, with respect to postoperative pain control and treatment success.Materials and Methods:A total of 99 mandibular premolar and molar teeth will be included in this study. The teeth will be randomly allocated into three groups (n = 33 per group): total pulpotomy, radicular pulpotomy, and root canal treatment.Root canal treatment will be performed using standardized endodontic protocols.Total pulpotomy will be carried out to the level of the canal orifices, followed by hemostasis achieved with 2.5% sodium hypochlorite (NaOCl). A 3-mm-thick layer of mineral trioxide aggregate (MTA) will be placed as the pulpotomy material.Radicular pulpotomy will be performed by removing the pulp tissue a few millimeters apical to the canal orifices. Hemostasis will be achieved using 2.5% NaOCl, and a 3-mm-thick layer of MTA will be placed as the pulpotomy agent.All treated teeth will be restored with glass ionomer cement, followed by a composite resin restoration.Postoperative pain intensity will be assessed using a visual analog scale (VAS) at the following time points: preoperatively, and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success and periapical health.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy patients of both sexes, aged between 15 and 45 years, with no systemic diseases, will be screened for inclusion in the study. Strict eligibility criteria will be applied.
The patients included in the study must have restorable, extremely deep carious lesions in the mandibular first and second molars, and first and second premolars; healthy periodontal status (periodontal pocket ≤ 3 mm); and a clinical diagnosis of symptomatic irreversible pulpitis (history of spontaneous pain, pain persisting after removal of the stimulus, exaggerated and prolonged response to cold testing, and a positive response to the electric pulp test).
Exclusion Criteria:
* Teeth with cracks or cusp fractures, subgingival caries, or periapical radiolucency will not be included in the study.
Informed consent will be obtained from all included patients.
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.