Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

Juan Gonzalo Olivieri220 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Endodontic Disease Endodontically Treated Teeth

Interventions

BioRoot RCS® root canal sealerOTHER

Root canal obturation with guttapercha and BioRoot RCS® root canal sealer

AH Plus® root canal sealerOTHER

Root canal obturation with guttapercha and AH Plus® root canal sealer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Clinical post-operative pain

VAS score of patient' level of pain, from no pain to extreme pain

Time frame: Immediately post-treatment.

Clinical post-operative pain

VAS score of patient' level of pain, from no pain to extreme pain

Time frame: 4 hours post-treatment

Clinical post-operative pain

VAS score of patient' level of pain, from no pain to extreme pain

Time frame: 24 hours post treatment

Clinical post-operative pain

VAS score of patient' level of pain, from no pain to extreme pain

Time frame: 48 hours post treatment

Clinical signs or symptoms of periapical disease

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 1 year

Clinical signs or symptoms of periapical disease

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 2 years

Clinical signs or symptoms of periapical disease

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 4 years

Clinical signs or symptoms of periapical disease

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 6 years

Radiographic periapical healing

Data from ClinicalTrials.gov

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Secondary Outcomes

Correlation of prognostic factors and clinical signs or symptoms of periapical disease

Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having 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

Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to radiographic periapical Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

Time frame: 1 year

Correlation of prognostic factors and radiographic periapical healing

Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

Time frame: 2 years

Correlation of prognostic factors and radiographic periapical healing

Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

Time frame: 4 years

Correlation of prognostic factors and radiographic periapical healing

Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

Time frame: 6 years