NCT07375576 Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis
| NCT ID | NCT07375576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mustafa Kemal University |
| Condition | Post-operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 99 participants in total. It began in 2025-12-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07375576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Post-operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07375576 currently recruiting?
Yes, NCT07375576 is actively recruiting participants. Contact the research team at efkanaksay@gmail.com for enrollment information.
Where is the NCT07375576 trial being conducted?
This trial is being conducted at Hatay, Turkey (Türkiye).
Who is sponsoring the NCT07375576 clinical trial?
NCT07375576 is sponsored by Mustafa Kemal University. The trial plans to enroll 99 participants.