Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528979
• Other study ID #: UICENDECL201703
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: January 2027

Study information

• Verified date: August 2020
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 2027
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

Other:
• BioRoot RCS® root canal sealer
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
• AH Plus® root canal sealer
Root canal obturation with guttapercha and AH Plus® root canal sealer

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan Gonzalo Olivieri

Country where clinical trial is conducted

Spain, 

Outcome

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