Endodontic DiseaseNCT04528979
Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
A study testing BioRoot RCS® root canal sealer and AH Plus® root canal sealer in people with Endodontic Disease and Endodontically Treated Teeth, run by Juan Gonzalo Olivieri at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Endodontically Treated Teeth
- What is being tested?
- BioRoot RCS® root canal sealer and AH Plus® root canal sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2019to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Juan G. Olivieri, DDS, PhD, 935042000, jgolivieri@uic.es
About this study
Official title: 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.
- Conditions
- Endodontic Disease, Endodontically Treated Teeth
- Being tested
- BioRoot RCS® root canal sealer, AH Plus® root canal sealer
- Keywords
- Primary root canal treatment, Secondary root canal treatment, Outcome, Root canal sealer
- Medical subject headings
- Dental Pulp Diseases, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioRoot RCS® root canal sealerOther
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
AH Plus® root canal sealerOther
Root canal obturation with guttapercha and AH Plus® root canal sealer
| Study group | Role | What they receive |
|---|---|---|
| Primary root canal treatment | Experimental | Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers Receives: Other: BioRoot RCS® root canal sealer; Other: AH Plus® root canal sealer |
| Secondary root canal treatment | Experimental | Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers Receives: Other: BioRoot RCS® root canal sealer; Other: AH Plus® root canal sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: Immediately post-treatment.
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: 4 hours post-treatment
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: 24 hours post treatment
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Measured: 48 hours post treatment
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Measured: 1 year
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Measured: 2 years
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Measured: 4 years
Clinical signs or symptoms of periapical disease
Absence/presence of clinical signs or symptoms of periapical disease
Measured: 6 years
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Measured: 1 year
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Measured: 2 years
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Measured: 4 years
Radiographic periapical healing
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Measured: 6 years
Secondary outcomes (8)
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
Measured: 1 year
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
Measured: 2 years
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
Measured: 4 years
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
Measured: 6 years
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
Measured: 1 year
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
Measured: 2 years
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
Measured: 4 years
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
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start20 Sep 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Gonzalo Olivieri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Gonzalo Olivieri, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528979
- Sponsor's protocol ID
- UICENDECL201703
- Status last verified
- Aug 2020
- First submitted
- 21 May 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04528979
- Acronym / sponsor ID
- UICENDECL201703
- Conditions
- Endodontic Disease, Endodontically Treated Teeth
- Keywords
- Primary root canal treatment, Secondary root canal treatment, Outcome, Root canal sealer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Juan Gonzalo OlivieriUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary root canal treatment | Experimental | Other: BioRoot RCS® root canal sealer, Other: AH Plus® root canal sealerPrimary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers |
| Secondary root canal treatment | Experimental | Other: BioRoot RCS® root canal sealer, Other: AH Plus® root canal sealerSecondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioRoot RCS® root canal sealerRoot canal obturation with guttapercha and BioRoot RCS® root canal sealer | Other | Primary root canal treatment, Secondary root canal treatment |
| AH Plus® root canal sealerRoot canal obturation with guttapercha and AH Plus® root canal sealer | Other | Primary root canal treatment, Secondary root canal treatment |
Primary outcome
Clinical post-operative pain
Time frame: Immediately post-treatment.
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
Time frame: 4 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
Time frame: 24 hours post treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
Time frame: 48 hours post treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of periapical disease
Time frame: 1 year
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease
Time frame: 2 years
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease
Time frame: 4 years
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease
Time frame: 6 years
Absence/presence of clinical signs or symptoms of periapical disease
Radiographic periapical healing
Time frame: 1 year
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing
Time frame: 2 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing
Time frame: 4 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical healing
Time frame: 6 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
8 secondary outcomes
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time frame: 1 year
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time frame: 2 years
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time frame: 4 years
Correlation of prognostic factors and clinical signs or symptoms of periapical disease
Time frame: 6 years
Correlation of prognostic factors and radiographic periapical healing
Time frame: 1 year
Correlation of prognostic factors and radiographic periapical healing
Time frame: 2 years
Correlation of prognostic factors and radiographic periapical healing
Time frame: 4 years
Correlation of prognostic factors and radiographic periapical healing
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioRoot RCS® root canal sealer and AH Plus® root canal sealer in people with Endodontic Disease and Endodontically Treated Teeth, run by Juan Gonzalo Olivieri at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical post-operative pain (time frame: Immediately post-treatment.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.