Evaluating the success of different root canal sealers in dental treatment
The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
This study is testing whether two different root canal sealers can help people with serious tooth problems get better results from their dental treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 1 site (Sant Cugat del Vallès, Barcelona) |
| Trial ID | NCT04528979 on ClinicalTrials.gov |
What this trial studies
This study is a prospective randomized controlled trial that aims to assess the success rates of endodontic treatment and retreatment using two different root canal sealers: BioRoot™ RCS and AH Plus. Patients diagnosed with irreversible pulpitis or apical periodontitis will be enrolled and followed for up to six years to compare the effectiveness of these sealers. The study will test the hypothesis that there are no significant differences in treatment success rates between the two sealers. Participants will be required to provide informed consent and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates include patients with irreversible pulpitis or apical periodontitis who require endodontic treatment or retreatment.
Not a fit: Patients with systemic diseases, root resorption, or those for whom root canal treatment is not the appropriate option may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes in root canal treatments, enhancing patient satisfaction and reducing the need for retreatment.
How similar studies have performed: Other studies have explored the effectiveness of various root canal sealers, but this specific comparison of BioRoot™ RCS and AH Plus is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sant Cugat del Vallès, Barcelona
- Universitat Internacional de Catalunya — Sant Cugat del Vallès, Barcelona, Spain (Recruiting)
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.