Root Canal ObturationBioRoot RCSNCT05247138
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.
An observational study of Root Canal Obturation, run by Septodont at 9 sites in France.
Trial summary
The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Root Canal Obturation
- What is being tested?
- BioRootTM RCS
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 9 sitesFrance
- Study dates
- 18 Feb 2022to 1 Jul 2029
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patient in need of root canal treatment (or retreatment).
Who may be able to join
- Patient, male or female, > 18 years of age at the time of inclusion in the study.
- Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago.
- All roots of the investigational teeth were treated with BioRootTM RCS.
- Having a documented retro-alveolar radiography immediately after root canal obturation.
- Patient affiliated or beneficiary of a social security system.
- Patient has signed his/her informed consent form.
Who cannot join
- History of malignant tumors in the 5 years prior to the root canal treatment.
- Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.).
- Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS.
- The Root canal treatment with BioRootTM RCS is on a wisdom tooth.
- Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Cabinet dentaire
Dijon, 21000
Cabinet Dentaire
Levallois-Perret, Perret, 92300
Cabinet Dentaire
Muizon, 51140
Cabinet dentaire
Paris, 75006
Cabinet dentaire
Paris, 75009
Cabinet dentaire
Plérin, 22190
Cabinet dentaire
Saint-Amand-sur-Sèvre, 79700
Cabinet dentaire
Sézanne, 51120
Cabinet Medical
Villiers-sur-Marne, 94350
About this study
Official title: Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study
The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.
Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.
- Conditions
- Root Canal Obturation
- Being tested
- BioRootTM RCS
- Keywords
- Root Canal Sealer, Endodontic Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioRootTM RCSDevice
BioRoot™ RCS is a hydrophilic mineral root canal sealer prepared from the mixture of a powder part and a liquid part. BioRoot™ RCS is a class III implantable medical device. This device is intended to be used in dentistry for permanent obturation of root canals of permanent and mature teeth with adjunction of gutta-percha points. Exposure to the sealer BioRootTM RCS starts from the day when the root canal treatment is performed until the end of individual observational period or the removal of the sealer in case of extraction or retreatment, if this event occurs before the end of individual observational period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiological performance impact of the endodontic treatment at 5 years.
The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment.
Measured: At 5 years post treatment
Secondary outcomes (7)
Clinical and radiological performance impact of the endodontic treatment at 10 years.
The "success" and "failure" of the 10-year clinical and radiological performance impact of the endodontic treatment.
- Absence of pain
- Absence of clinical evidence of infection, inflammation or swelling
- Normal periodontal ligament space (PAI score ≤ 2)
- "failure" of the endodontic treatment occur if the investigational tooth met one of the following criteria:
- had been extracted for endodontic reasons since the root canal filling
- Had been retreated since the root canal filling
- Had undergone a periapical surgery since the root canal treatment
- Presence of pain
- Presence of clinical evidence of infection, inflammation or swelling
- PAI score ≥ 3
Measured: At 10 years post treatment
Evaluation of the need of treatment or retreatment at 5 and 10 years.
"The "success" and "failure" of the endodontic treatment at 5 and 10 years according treatment or retreatment.
Measured: At 5 and 10 Years post treatment
Assessment of the "tooth functional retention" at 5 and 10 years.
The success and failure of the "tooth functional retention" at 5 and 10 years after Root Canal Treatment with BioRoot™ RCS.
Measured: At 5 and 10 Years post treatment
The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment.
The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment "Not resorbable once hardened", "Not retractable over the years" and "Radiopaque" will be evaluated in patients with retro-alveolar radiographs at the follow-up consultation (in parallel of the baseline consultation). The technical characteristics are defined as follows:
- no resorption of the filling cement in the root, detectable on radiography
- dense and homogeneous filling, limited to the canal
- a filling with the maintenance of the canal anatomy
Measured: At 5 and 10 Years post treatment
The ease of use and insertion of BioRootTM RCS in the canal.
The ease of use and insertion of BioRootTM RCS in the canal will be evaluated with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes).
Measured: At 5 years post treatment
The Investigator overall satisfaction of the experience with BioRootTM RCS.
The Investigator overall satisfaction of the experience with BioRootTM RCS will be evaluated at 5 and 10 years after Root Canal Obturation with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes).
Measured: At 5 and 10 Years post treatment
The post-obturation adverse device effects.
The post-obturation adverse device effects will be evaluated with the list of adverse events occurring between the date of the root canal filling and the 5-year visit and between the 5-year visit and the 10-year visit.
Measured: At baseline visit, 5 and 10 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start18 Feb 2022
- Primary completion7 Nov 2025
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal ObturationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EndoData, Recherche Clinique en Odontologie (ReCOL)
- Responsible party
- Sponsor
- Investigators
- Brigitte Grosgogeat, MD, PhD, Study director, CHU de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247138
- Sponsor's protocol ID
- BIOR 2021-04
- Acronym
- BioRoot RCS
- Status last verified
- Apr 2026
- First submitted
- 28 Dec 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study
- ClinicalTrials.gov ID
- NCT05247138
- Acronym / sponsor ID
- BioRoot RCS / BIOR 2021-04
- Conditions
- Root Canal Obturation
- Keywords
- Root Canal Sealer, Endodontic Treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Collaborators
- EndoData, Recherche Clinique en Odontologie (ReCOL)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 18 Feb 2022 (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.
The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.
Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient in need of root canal treatment (or retreatment).
Key inclusion criteria (6 listed)
- Patient, male or female, > 18 years of age at the time of inclusion in the study.
- Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago.
- All roots of the investigational teeth were treated with BioRootTM RCS.
- Having a documented retro-alveolar radiography immediately after root canal obturation.
- Patient affiliated or beneficiary of a social security system.
Key exclusion criteria (5 listed)
- History of malignant tumors in the 5 years prior to the root canal treatment.
- Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.).
- Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS.
- The Root canal treatment with BioRootTM RCS is on a wisdom tooth.
- Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).
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 |
|---|---|---|
| BioRootTM RCSBioRoot™ RCS is a hydrophilic mineral root canal sealer prepared from the mixture of a powder part and a liquid part. BioRoot™ RCS is a class III implantable medical device. This device is intended to be used in dentistry for permanent obturation of root canals of permanent and mature teeth with adjunction of gutta-percha points. Exposure to the sealer BioRootTM RCS starts from the day when the root canal treatment is performed until the end of individual observational period or the removal of the sealer in case of extraction or retreatment, if this event occurs before the end of individual observational period. | Device | – |
Primary outcome
Clinical and radiological performance impact of the endodontic treatment at 5 years.
Time frame: At 5 years post treatment
The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment.
7 secondary outcomes
Clinical and radiological performance impact of the endodontic treatment at 10 years.
Time frame: At 10 years post treatment
Evaluation of the need of treatment or retreatment at 5 and 10 years.
Time frame: At 5 and 10 Years post treatment
Assessment of the "tooth functional retention" at 5 and 10 years.
Time frame: At 5 and 10 Years post treatment
The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment.
Time frame: At 5 and 10 Years post treatment
The ease of use and insertion of BioRootTM RCS in the canal.
Time frame: At 5 years post treatment
The Investigator overall satisfaction of the experience with BioRootTM RCS.
Time frame: At 5 and 10 Years post treatment
The post-obturation adverse device effects.
Time frame: At baseline visit, 5 and 10 years post treatment
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 6 May 2026.
- 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. This study is not recruiting at the moment.
Brigitte Grosgogeat, MD, PhD study director
CHU de Lyon, France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal Obturation, run by Septodont at 9 sites in France.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiological performance impact of the endodontic treatment at 5 years. (time frame: At 5 years post treatment). 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 6 May 2026.