Endodontically Treated TeethNCT05084742
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
An observational study of Endodontically Treated Teeth, run by Septodont at 6 sites in France.
Trial summary
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed: Repair of root or furcation perforations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Biodentine™
- Type of treatment
- Medical device
- How many people
- 145 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Nov 2021to Sep 2033
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 160 patients with a permanent tooth treated at least 1 year and no more than 5.5 years ago through an endodontic microsurgery using Biodentine™, all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization.
Who may be able to join
- Male or female, adult or child with permanent study tooth (immature or mature)
- Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification
- Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit
- Availability of baseline radiographic image of the study tooth
- Patient affiliated to national health insurance
- Patient informed about the study and who confirms his/her consent to participate to the study
Who cannot join
- Patient treated with anti-cancer therapy in the 5 years prior to the treatment
- Uncontrolled systemic disease 1 month prior to the treatment
- Development of a cancer or a systemic disease just after the treatment
- Participation to an interventional clinical trial at the time of the treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
AP-HP, Hôpital Louis Mourier
Colombes
HCL de Lyon
Lyon
CHU de Nantes
Nantes
Private dental care office
Paris
CHU de Reims
Reims
CHU de Toulouse
Toulouse
About this study
Official title: Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:
- Repair of root or furcation perforations.
- Repair of root resorptions (internal and external).
- Root-end filling in endodontic surgery (retrograde filling).
- Apexification (tooth with open apex).
- Revitalization procedure by means of revascularization.
Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Biodentine™
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine™Device
Biodentine™ is a bioactive dentin substitute from the " Active Biosilicate Technology® " innovation.
Study participants were treated from 1 year to 5,5 years ago through an endodontic microsurgery using Biodentine™ used in its endodontic indications, i.e., root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success of treatment
The proportion of patients with successfull treatment at 10 years post-surgery will be determined on clinical and radiographic success evidences for each endodontic indication of Biodentine™:
- In root end-filling
- In root resorption repair (internal, external)
- In root and furcation perforation repair
- In apexification
- In revitalization procedure by means of revascularization
Measured: At 10 years post-treatment
Secondary outcomes (1)
Number of Adverse Events (AE) and device deficiencies
Safety at 10 years post-surgery will be determined based on the cumulative numbers of Adverse Events (AE) and device deficiencies observed from treatment onset to 10 years post-treatment, for each endodontic indication of Biodentine™:
- In root end-filling
- In root resorption repair (internal, external)
- In root and furcation perforation repair
- In apexification
- In revitalization procedure by means of revascularization
Measured: From treatment onset to 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 posted20 Oct 2021
- Study start8 Nov 2021
- Primary completion23 Apr 2024
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EndoData, Recherche Clinique en Odontologie (ReCOL), QualityStat
- Responsible party
- Sponsor
- Investigators
- Brigitte Grosgogeat, MD, PhD, Study director, CHU de Lyon, FranceMarie Georgelin Gurgel, MD, Principal investigator, CHU de Toulouse, FranceAnne-Margaux Collignon, MD, Principal investigator, AP-HP, Hôpital Louis Mourier, Colombes, FranceAlexis Gaudin, MD, Principal investigator, CHU de Nantes, FranceCyril Villat, MD, PhD, Principal investigator, HCL de Lyon, FranceMarie-Paule Gellé, MD, Principal investigator, CHU de Reims, FranceSandrine Dahan, MD, Principal investigator, Private dental practice, Paris, FranceGrégory Caron, MD, Principal investigator, Private dental practice, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084742
- Sponsor's protocol ID
- BIOD2021-03
- Other IDs
- 2021-A01631-40
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guidez C, Couvrechel C, Grosgogeat B, Collignon AM. Long-term evaluation of calcium silicate-based cement in endodontic indications: Five-year results on effectiveness and safety. J Dent. 2026 Jan;164:106217. doi: 10.1016/j.jdent.2025.106217. Epub 2025 Nov 7.
PubMed 41207457
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
- Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
- ClinicalTrials.gov ID
- NCT05084742
- Acronym / sponsor ID
- BIOD2021-03
- Conditions
- Endodontically Treated Teeth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (actual)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Collaborators
- EndoData, Recherche Clinique en Odontologie (ReCOL), QualityStat
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- Sep 2033 (estimated)
- First posted
- 20 Oct 2021 (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.
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:
- Repair of root or furcation perforations.
- Repair of root resorptions (internal and external).
- Root-end filling in endodontic surgery (retrograde filling).
- Apexification (tooth with open apex).
- Revitalization procedure by means of revascularization.
Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 160 patients with a permanent tooth treated at least 1 year and no more than 5.5 years ago through an endodontic microsurgery using Biodentine™, all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization.
Key inclusion criteria (6 listed)
- Male or female, adult or child with permanent study tooth (immature or mature)
- Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification
- Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit
- Availability of baseline radiographic image of the study tooth
- Patient affiliated to national health insurance
Key exclusion criteria (4 listed)
- Patient treated with anti-cancer therapy in the 5 years prior to the treatment
- Uncontrolled systemic disease 1 month prior to the treatment
- Development of a cancer or a systemic disease just after the treatment
- Participation to an interventional clinical trial at the time of the treatment
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 |
|---|---|---|
| Biodentine™Biodentine™ is a bioactive dentin substitute from the " Active Biosilicate Technology® " innovation. Study participants were treated from 1 year to 5,5 years ago through an endodontic microsurgery using Biodentine™ used in its endodontic indications, i.e., root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization. | Device | – |
Primary outcome
Clinical and radiographic success of treatment
Time frame: At 10 years post-treatment
The proportion of patients with successfull treatment at 10 years post-surgery will be determined on clinical and radiographic success evidences for each endodontic indication of Biodentine™: * In root end-filling * In root resorption repair (internal, external) * In root and furcation perforation repair * In apexification * In revitalization procedure by means of revascularization
1 secondary outcome
Number of Adverse Events (AE) and device deficiencies
Time frame: From treatment onset to 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.
- Results publication: PubMed 41207457Guidez C, Couvrechel C, Grosgogeat B, Collignon AM. Long-term evaluation of calcium silicate-based cement in endodontic indications: Five-year results on effectiveness and safety. J Dent. 2026 Jan;164:106217. doi: 10.1016/j.jdent.2025.106217. Epub 2025 Nov 7.
- 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
Marie Georgelin Gurgel, MD principal investigator
CHU de Toulouse, France
Anne-Margaux Collignon, MD principal investigator
AP-HP, Hôpital Louis Mourier, Colombes, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endodontically Treated Teeth, run by Septodont at 6 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 4 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 6 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 radiographic success of treatment (time frame: At 10 years post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084742, which also lists 1 linked publication.
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.