- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528979
Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
August 27, 2020 updated by: Juan Gonzalo Olivieri
The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Sant Cugat Del Vallès, Barcelona, Spain, 08195
- Recruiting
- Universitat Internacional de Catalunya
-
Contact:
- Juan G. Olivieri, DDS, PhD
- Phone Number: 935042000
- Email: jgolivieri@uic.es
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primary root canal treatment
Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
|
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
Root canal obturation with guttapercha and AH Plus® root canal sealer
|
Experimental: Secondary root canal treatment
Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers
|
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
Root canal obturation with guttapercha and AH Plus® root canal sealer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical post-operative pain
Time Frame: Immediately post-treatment.
|
VAS score of patient' level of pain, from no pain to extreme pain
|
Immediately post-treatment.
|
Clinical post-operative pain
Time Frame: 4 hours post-treatment
|
VAS score of patient' level of pain, from no pain to extreme pain
|
4 hours post-treatment
|
Clinical post-operative pain
Time Frame: 24 hours post treatment
|
VAS score of patient' level of pain, from no pain to extreme pain
|
24 hours post treatment
|
Clinical post-operative pain
Time Frame: 48 hours post treatment
|
VAS score of patient' level of pain, from no pain to extreme pain
|
48 hours post treatment
|
Clinical signs or symptoms of periapical disease
Time Frame: 1 year
|
Absence/presence of clinical signs or symptoms of periapical disease
|
1 year
|
Clinical signs or symptoms of periapical disease
Time Frame: 2 years
|
Absence/presence of clinical signs or symptoms of periapical disease
|
2 years
|
Clinical signs or symptoms of periapical disease
Time Frame: 4 years
|
Absence/presence of clinical signs or symptoms of periapical disease
|
4 years
|
Clinical signs or symptoms of periapical disease
Time Frame: 6 years
|
Absence/presence of clinical signs or symptoms of periapical disease
|
6 years
|
Radiographic periapical healing
Time Frame: 1 year
|
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
|
1 year
|
Radiographic periapical healing
Time Frame: 2 years
|
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
|
2 years
|
Radiographic periapical healing
Time Frame: 4 years
|
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
|
4 years
|
Radiographic periapical healing
Time Frame: 6 years
|
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
|
6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 1 year
|
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
|
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 2 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
|
2 years
|
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 4 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
|
4 years
|
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time Frame: 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
|
6 years
|
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 1 year
|
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
|
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 2 years
|
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
|
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 4 years
|
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
|
Correlation of prognostic factors and radiographic periapical healing
Time Frame: 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
|
6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2019
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2027
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
August 23, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 31, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UICENDECL201703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endodontic Disease
-
Damascus UniversityCompletedEndodontic Disease | Endodontic Re-treatment FailureSyrian Arab Republic
-
Cairo UniversityUnknownEndodontic Disease | Endodontic Re-treatment Failure
-
Nuh Naci Yazgan UniversityMersin UniversityCompletedEndodontic Disease | Endodontic InflammationTurkey
-
Lumendo AGAvaniaNot yet recruitingEndodontic TreatmentTurkey
-
University of North Carolina, Chapel HillWithdrawnLocal Anesthesia | Endodontic Disease | Endodontic Inflammation | Dental Anesthesia
-
Istanbul UniversityAbant Izzet Baysal University; Istanbul Kent UniversityCompletedApexification | Regenerative Endodontic | FractalsTurkey
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriodontal and Endodontic LesionIndia
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriodontal and Endodontic Lesion
-
PAULO VINICIUS SOARESUnknownMTA | Calcium Hydroxide | Endodontic TreatmentBrazil
-
University Hospital, BrestRecruiting
Clinical Trials on BioRoot RCS® root canal sealer
-
SeptodontSlb PharmaActive, not recruitingRoot Canal ObturationFrance, Belgium
-
Hui ChenCompletedApical Periodontitis | Irreversible Pulpitis
-
Ege UniversityCompletedAsymptomatic Vital Mandibular Molar TeethTurkey
-
Cukurova UniversityCompletedEndodontically-Treated Teeth
-
British University In EgyptRecruitingPost Operative PainEgypt
-
Cairo UniversityUnknown
-
ACTEON GroupSlb PharmaCompletedRoot Canal ObturationFrance
-
University of BolognaCompletedEndodontically Treated TeethItaly
-
Postgraduate Institute of Dental Sciences RohtakCompleted
-
Ministry of Health, KuwaitEnrolling by invitationPeriapical Diseases | Root Canal InfectionKuwait