Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Evaluating the success of different root canal sealers in dental treatment

Official title: The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study

Run by Universitat Internacional de Catalunya · NCT04528979 · Data updated 2026-11-12

This study is testing whether two different root canal sealers can help people with serious tooth problems get better results from their dental treatments.

More Endodontically Treated Teeth trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment220 (estimated)
SponsorUniversitat Internacional de Catalunya
Academic / other
Locations1 site (Sant Cugat del Vallès, Barcelona)
StatusRecruiting
StartedSeptember 20, 2019
Main results expectedJanuary 2021
Study endsJanuary 2027
Registry record updatedAugust 31, 2020
Trial IDNCT04528979 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with irreversible pulpitis or apical periodontitis who require endodontic treatment or retreatment.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have explored the effectiveness of various root canal sealers, but this specific comparison of BioRoot™ RCS and AH Plus is relatively novel.

Who can join: the full rules

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 it's running

  • Universitat Internacional de Catalunya
    Sant Cugat del Vallès, Barcelona, Spain
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.