Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

Juan Gonzalo Olivieri

Status: Enrolling

Conditions: Endodontic Disease; Endodontically Treated Teeth

Treatments: Other: BioRoot RCS® root canal sealer; Other: AH Plus® root canal sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT04528979

UICENDECL201703

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Primary root canal treatment

Experimental group

Description:

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

Treatment:

Other: AH Plus® root canal sealer

Other: BioRoot RCS® root canal sealer

Secondary root canal treatment

Experimental group

Description:

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

Treatment:

Other: AH Plus® root canal sealer

Other: BioRoot RCS® root canal sealer