BioRoot RCS® root canal sealer: Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
AH Plus® root canal sealer: Root canal obturation with guttapercha and AH Plus® root canal sealer
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Clinical post-operative pain — Immediately post-treatment. VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain — 4 hours post-treatment VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain — 24 hours post treatment VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain — 48 hours post treatment VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of periapical disease — 1 year Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease — 2 years Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease — 4 years Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease — 6 years Absence/presence of clinical signs or symptoms of periapical disease
Radiographic periapical healing — 1 year Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing — 2 years Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing — 4 years Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing — 6 years Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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