MedDataX Logo

Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

NCT ID: NCT04528979

Last Updated: 2020-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endodontic Disease Endodontically Treated Teeth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Primary root canal treatment Secondary root canal treatment Outcome Root canal sealer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Primary root canal treatment

Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers

Group Type EXPERIMENTAL

BioRoot RCS® root canal sealer

Intervention Type OTHER

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

AH Plus® root canal sealer

Intervention Type OTHER

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

Secondary root canal treatment

Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers

Group Type EXPERIMENTAL

BioRoot RCS® root canal sealer

Intervention Type OTHER

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

AH Plus® root canal sealer

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BioRoot RCS® root canal sealer

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

Intervention Type OTHER

AH Plus® root canal sealer

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Juan Gonzalo Olivieri

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Juan Gonzalo Olivieri

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Juan G. Olivieri, DDS, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UICENDECL201703

Identifier Type: -

Identifier Source: org_study_id