Clinical trial NCT04528979: Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
Official title: The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endodontic Disease
Endodontically Treated Teeth
Keywords: Primary root canal treatment
Secondary root canal treatment
Outcome
Root canal sealer
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Clinical post-operative pain
timeFrame: Immediately post-treatment.
measure: Clinical post-operative pain
timeFrame: 4 hours post-treatment
measure: Clinical post-operative pain
timeFrame: 24 hours post treatment
measure: Clinical post-operative pain
timeFrame: 48 hours post treatment
measure: Clinical signs or symptoms of periapical disease
timeFrame: 1 year
measure: Clinical signs or symptoms of periapical disease
timeFrame: 2 years
measure: Clinical signs or symptoms of periapical disease
timeFrame: 4 years
measure: Clinical signs or symptoms of periapical disease
timeFrame: 6 years
measure: Radiographic periapical healing
timeFrame: 1 year
measure: Radiographic periapical healing
timeFrame: 2 years
measure: Radiographic periapical healing
timeFrame: 4 years
measure: Radiographic periapical healing
timeFrame: 6 years
Secondary outcomes:
measure: Correlation of prognostic factors and clinical signs or symptoms of periapical disease
timeFrame: 1 year
measure: Correlation of prognostic factors and clinical signs or symptoms of periapical disease
timeFrame: 2 years
measure: Correlation of prognostic factors and clinical signs or symptoms of periapical disease
timeFrame: 4 years
measure: Correlation of prognostic factors and clinical signs or symptoms of periapical disease
timeFrame: 6 years
measure: Correlation of prognostic factors and radiographic periapical healing
timeFrame: 1 year
measure: Correlation of prognostic factors and radiographic periapical healing
timeFrame: 2 years
measure: Correlation of prognostic factors and radiographic periapical healing
timeFrame: 4 years
measure: Correlation of prognostic factors and radiographic periapical healing
timeFrame: 6 years
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: