Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

Not Applicable

Recruiting

• Conditions: Endodontic Disease; Endodontically Treated Teeth
• Interventions: Other: BioRoot RCS® root canal sealer; Other: AH Plus® root canal sealer

• Registration Number: NCT04528979
• Lead Sponsor: Juan Gonzalo Olivieri

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-20
• Study First Submitted: 2020-05-21
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-23
• Study First Posted: 2020-08-27
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-31
• Primary Completion: 2021-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary root canal treatment	BioRoot RCS® root canal sealer	Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Primary root canal treatment	BioRoot RCS® root canal sealer	Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Primary root canal treatment	AH Plus® root canal sealer	Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Secondary root canal treatment	AH Plus® root canal sealer	Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers

Primary Outcome Measures

Name	Time	Method
Clinical post-operative pain	48 hours post treatment	VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of periapical disease	6 years	Absence/presence of clinical signs or symptoms of periapical disease
Radiographic periapical healing	6 years	Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph

Secondary Outcome Measures

Name	Time	Method
Correlation of prognostic factors and clinical signs or symptoms of periapical disease	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
Correlation of prognostic factors and radiographic periapical healing	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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain