Postoperative pain after root canal filling with bioceramic or resin-based sealers.
Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers
NA · University of Siena · NCT07018284
This project will see if using bioceramic versus resin-based sealers for root canal fillings changes short-term pain in adults with pulpitis, pulp necrosis, or previously treated teeth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Siena (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT07018284 on ClinicalTrials.gov |
What this trial studies
Adults (≥18) with teeth diagnosed with irreversible pulpitis, pulp necrosis, or previously treated endodontic cases will receive root canal obturation using either a bioceramic sealer (NeoSealer Flo) or a resin-based sealer (AH Plus) with standardized obturation techniques (single-cone or continuous wave condensation). Patients will record pain intensity on a Visual Analogue Scale immediately after treatment, at 24 hours, and at 72 hours. The primary comparison is the incidence and intensity of early postoperative pain between the two sealer groups to determine whether sealer type influences short-term discomfort. The study is conducted at Universidad Rey Juan Carlos in Madrid in collaboration with the University of Siena.
Who should consider this trial
Good fit: Adults aged 18 and older undergoing root canal treatment for irreversible pulpitis, pulp necrosis, or retreatment who can provide informed consent and have adequate clinical and radiographic records are ideal candidates.
Not a fit: Patients who are asymptomatic, have root fractures, resorption, open apices, uncontrolled systemic conditions that impair healing, or inadequate radiographs are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose obturation materials that reduce short-term pain after root canal treatment.
How similar studies have performed: Prior clinical studies comparing bioceramic and resin-based sealers have shown mixed results, with some suggesting slightly less postoperative pain with bioceramics but no definitive consensus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. Informed consent provided for data usage. Exclusion Criteria: * Patients with systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunosuppression). * Asymptomatic presentation * Teeth with root fractures, resorption, or open apices. * Incomplete clinical or radiographic records. * Cases with poor-quality radiographs or lack of standardization for evaluation
Where this trial is running
Madrid
- Universidad Rey Juan Carlos , Madrid, Spain 28922 — Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Simone Grandini, PhD — University of Siena
- Study coordinator: Giulia Malvicini, DDS
- Email: giulia.malvicini@student.unisi.it
- Phone: Italia: +39 3487200168
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.
Conditions: Periapical Periodontitis, Pulpitis, Necorsis, Bioceramic sealers, Resin-based sealers, Endodontics