Back to resultsOutcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
Primary Purpose
Endodontic Disease, Endodontically Treated Teeth
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BioRoot RCS® root canal sealer
AH Plus® root canal sealer
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease focused on measuring Primary root canal treatment, Secondary root canal treatment, Outcome, Root canal sealer
Eligibility Criteria
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.
Sites / Locations
- Universitat Internacional de CatalunyaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Primary root canal treatment
Secondary root canal treatment
Arm Description
Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Outcomes
Primary Outcome Measures
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Secondary Outcome Measures
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04528979
Brief Title
Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
Official Title
The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan Gonzalo Olivieri
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Endodontically Treated Teeth
Keywords
Primary root canal treatment, Secondary root canal treatment, Outcome, Root canal sealer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Primary root canal treatment
Arm Type
Experimental
Arm Description
Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Arm Title
Secondary root canal treatment
Arm Type
Experimental
Arm Description
Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
Intervention Type
Other
Intervention Name(s)
BioRoot RCS® root canal sealer
Intervention Description
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
Intervention Type
Other
Intervention Name(s)
AH Plus® root canal sealer
Intervention Description
Root canal obturation with guttapercha and AH Plus® root canal sealer
Primary Outcome Measure Information:
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
Immediately post-treatment.
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
4 hours post-treatment
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
24 hours post treatment
Title
Clinical post-operative pain
Description
VAS score of patient' level of pain, from no pain to extreme pain
Time Frame
48 hours post treatment
Title
Clinical signs or symptoms of periapical disease
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
1 year
Title
Clinical signs or symptoms of periapical disease
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
2 years
Title
Clinical signs or symptoms of periapical disease
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
4 years
Title
Clinical signs or symptoms of periapical disease
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
6 years
Title
Radiographic periapical healing
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
1 year
Title
Radiographic periapical healing
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
2 years
Title
Radiographic periapical healing
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
4 years
Title
Radiographic periapical healing
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Description
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
Time Frame
1 year
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Description
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
Time Frame
2 years
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Description
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
Time Frame
4 years
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Description
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
Time Frame
6 years
Title
Correlation of prognostic factors and radiographic periapical healing
Description
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
Time Frame
1 year
Title
Correlation of prognostic factors and radiographic periapical healing
Description
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing
Time Frame
2 years
Title
Correlation of prognostic factors and radiographic periapical healing
Description
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing
Time Frame
4 years
Title
Correlation of prognostic factors and radiographic periapical healing
Description
Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan G. Olivieri, DDS, PhD
Phone
935042000
Email
jgolivieri@uic.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
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