NCT04528979 Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
| NCT ID | NCT04528979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Juan Gonzalo Olivieri |
| Condition | Endodontic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2019-09-20 |
| Primary Completion | 2021-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.
Eligibility Criteria
Inclusion Criteria: * Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form. * Understands and is willing to comply with all study procedures and restrictions. * Not presence of clinically significant and relevant abnormalities of clinical history or oral examination. * Diagnosis of irreversible pulpitis or apical symptomatic / asymptomatic periodontitis. * Retreatment cases due to an endodontic failure. * Single or bi-radicular teeth. Exclusion Criteria: * General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities. * Specific: root resorption, root fractures, impossibility of restoration and cases were primary or secondary root canal treatment is not the treatment of choice.