Pulpotomy versus root canal for painful lower premolars and molars
Evaluation of the Outcomes of Total Pulpotomy, Radicular Pulpotomy, and Root Canal Treatment in Teeth With Extremely Deep Caries and Symptomatic Irreversible Pulpitis
This study will see if total pulpotomy, radicular pulpotomy, or root canal treatment best controls postoperative pain and leads to successful outcomes for people aged 15–45 with symptomatic irreversible pulpitis in mandibular premolars and molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Mustafa Kemal University Academic / other |
| Locations | 1 site (Hatay, Antakya) |
| Trial ID | NCT07375576 on ClinicalTrials.gov |
What this trial studies
Ninety-nine mandibular premolars and molars with symptomatic irreversible pulpitis will be randomized equally to total pulpotomy, radicular pulpotomy, or conventional root canal treatment. Treatments are delivered under local anesthesia with rubber dam isolation and standardized protocols, including MTA placement for pulpotomy and conventional endodontic protocols for RCT. Hemostasis for pulpotomies is achieved with 2.5% NaOCl and the time to hemostasis is recorded; caries removal and access are standardized across groups. Primary outcomes include postoperative pain control and clinical/radiographic treatment success over the follow-up period.
Who should consider this trial
Good fit: Ideal candidates are healthy people aged 15–45 with restorable mandibular first or second molars or premolars diagnosed with symptomatic irreversible pulpitis, healthy periodontal status (pocket ≤ 3 mm), and no periapical radiolucency.
Not a fit: Patients with cracked or fractured teeth, subgingival caries, periapical radiolucency, non-restorable teeth, or relevant systemic disease are unlikely to benefit from inclusion in this protocol.
Why it matters
Potential benefit: If successful, less invasive pulpotomy options could provide faster, simpler treatment with good pain control and tooth preservation compared with conventional root canal therapy.
How similar studies have performed: Recent clinical reports and trials have shown promising short- and medium-term success for pulpotomy in irreversible pulpitis, but long-term equivalence to root canal therapy is still being established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hatay, Antakya
- Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University — Hatay, Antakya, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Efkan Aksay
- Email: efkanaksay@gmail.com
- Phone: +905062654889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.