Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

August 27, 2020 updated by: Juan Gonzalo Olivieri

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

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 Overview

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08195
        • Recruiting
        • Universitat Internacional de Catalunya
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary root canal treatment
Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
Root canal obturation with guttapercha and AH Plus® root canal sealer
Experimental: Secondary root canal treatment
Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
Root canal obturation with guttapercha and AH Plus® root canal sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical post-operative pain
Time Frame: Immediately post-treatment.
VAS score of patient' level of pain, from no pain to extreme pain
Immediately post-treatment.
Clinical post-operative pain
Time Frame: 4 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
4 hours post-treatment
Clinical post-operative pain
Time Frame: 24 hours post treatment
VAS score of patient' level of pain, from no pain to extreme pain
24 hours post treatment
Clinical post-operative pain
Time Frame: 48 hours post treatment
VAS score of patient' level of pain, from no pain to extreme pain
48 hours post treatment
Clinical signs or symptoms of periapical disease
Time Frame: 1 year
Absence/presence of clinical signs or symptoms of periapical disease
1 year
Clinical signs or symptoms of periapical disease
Time Frame: 2 years
Absence/presence of clinical signs or symptoms of periapical disease
2 years
Clinical signs or symptoms of periapical disease
Time Frame: 4 years
Absence/presence of clinical signs or symptoms of periapical disease
4 years
Clinical signs or symptoms of periapical disease
Time Frame: 6 years
Absence/presence of clinical signs or symptoms of periapical disease
6 years
Radiographic periapical healing
Time Frame: 1 year
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
1 year
Radiographic periapical healing
Time Frame: 2 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
2 years
Radiographic periapical healing
Time Frame: 4 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
4 years
Radiographic periapical healing
Time Frame: 6 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 1 year
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
1 year
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 2 years
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
2 years
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 4 years
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
4 years
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 6 years
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
6 years
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 1 year
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
1 year
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 2 years
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing
2 years
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 4 years
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing
4 years
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 6 years
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

August 23, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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