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Recruiting NCT04528979

Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

No phase Interventional Endodontic Disease Endodontically Treated Teeth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BioRoot RCS® root canal sealer, AH Plus® root canal sealer.
Who it may be relevant to
Registry conditions: Endodontic Disease, Endodontically Treated Teeth. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other BioRoot RCS® root canal sealer
    Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
  • Other AH Plus® root canal sealer
    Root canal obturation with guttapercha and AH Plus® root canal sealer

Primary outcome measures

  • Clinical post-operative pain [Time frame: Immediately post-treatment.]
  • Clinical post-operative pain [Time frame: 4 hours post-treatment]
  • Clinical post-operative pain [Time frame: 24 hours post treatment]
  • Clinical post-operative pain [Time frame: 48 hours post treatment]
  • Clinical signs or symptoms of periapical disease [Time frame: 1 year]
  • Clinical signs or symptoms of periapical disease [Time frame: 2 years]
  • Clinical signs or symptoms of periapical disease [Time frame: 4 years]
  • Clinical signs or symptoms of periapical disease [Time frame: 6 years]
  • Radiographic periapical healing [Time frame: 1 year]
  • Radiographic periapical healing [Time frame: 2 years]
Secondary outcome measures (8)
  • Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Time frame: 1 year]
  • Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Time frame: 2 years]
  • Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Time frame: 4 years]
  • Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Time frame: 6 years]
  • Correlation of prognostic factors and radiographic periapical healing [Time frame: 1 year]
  • Correlation of prognostic factors and radiographic periapical healing [Time frame: 2 years]
  • Correlation of prognostic factors and radiographic periapical healing [Time frame: 4 years]
  • Correlation of prognostic factors and radiographic periapical healing [Time frame: 6 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universitat Internacional de Catalunya — Sant Cugat del Vallès

Identifiers

NCT: NCT04528979 · UICENDECL201703

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗