Dental Restoration, PermanentBIOD XPNCT06955429

Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

An observational study of Dental Restoration, Permanent and Dental Restorations, run by Septodont at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
What is being tested?: Dental restorative or endodontic treatment requiring Biodentine XP use
Type of treatment: Medical device
How many people: 275 participants
Where: 8 sitesin 2 countries
Study dates: 23 Oct 2025to 28 Feb 2037
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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Eligible patients are any male and female, adult patients who have undergone one of the following dental treatments using Biodentine™XP respecting the medical device indications.

Who may be able to join

Temporary tooth, from a child ≥ 2 years old, requiring dental restorative treatment with Biodentine™ XP, and/or, Permanent (mature or immature) tooth, from a child or an adult, requiring a dental restorative and/or an endodontic treatment with Biodentine™ XP.
Adult patient with a signed informed consent form; For the minor, if in age to understand, an assent is required, and at least one parent or legal representative must consent.
Only in France: Subject affiliated or benefiting from a social/health insurance system.

Who cannot join

Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
Inadequate expected tooth lifetime as estimated by the investigator:
For a Temporary tooth: high probability of tooth loss within 2 years after treatment with Biodentine™ XP.
For a permanent tooth: high probability of tooth loss within 10 years after treatment with Biodentine™ XP.
Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
Adult patient under legal protection measures or unable to express his/her consent, and individual deprived of liberty by judicial or administrative decision, as well as individual receiving psychiatric care.

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Periodontitis (stage 3, 4 or stage 2 grade C).
Inability to comply with study procedures.
Participation in another interventional clinical investigation that can induce bias in the study results.

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Operations Medical Affairs Department contact

1 49 76 70 00 ext. +33

clinical-operations@septodont.com

Country

City, postcode or hospital

Sites recruiting now only

8 sites in 2 countries

France6 sites, 6 recruiting

HCL Lyon
Lyon, 69002
Recruiting
Cabinet dentaire
Nantes, 44093
Recruiting
Cabinet dentaire
Paris, 75008
Recruiting
Hôpital Rotschild
Paris, 75012
Recruiting
Hôpital Pitié Salpêtrière
Paris, 75013
Recruiting
CHU Rennes
Rennes, 35000
Recruiting

Other trials in France

Belgium2 sites, 2 recruiting

Queen Astrid Dental Practice
Kraainem
Recruiting
UZ Leuven - University hospital
Leuven
Recruiting

Other trials in Belgium

About this study

Official title: Observational, Prospective, International and Multicenter Clinical Investigation Measuring the Longterm Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

Read the detailed description

This clinical investigation is done according to the European Medical Device Regulation (MDR) 2017/745 and is considered as an observational, post-market clinical follow-up study with no additional invasive and cumbersome procedures. Biodentine™ XP has been marketed in the US since 2022 and was launched in Europe in May 2023.

The aim of the study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in its coronal restorative and endodontic dental indications.

The investigators participating in the clinical investigation will be general dental surgeron practitioners, with a great experience in restorative and endodontic indications or in pediatric dentistry, also users of Biodentine™.

This Clinical Investigation is an Observational, Prospective, and Multicenter study. This clinical investigation will take place in several investigational centres in France and Belgium.

This Clinical InvestigatioI is a prospective study: Patients will be treated with the study device (according to its CE-marked Instruction For Use), then followed up.

Conditions: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
Being tested: Dental restorative or endodontic treatment requiring Biodentine XP use
Keywords: Dentine restoration, Coronal carious lesions, Restoration of cervical lesion, Restoration of radicular lesion, Pulp capping, Pulpotomy, Apexification, Revitalization, Endodontic treatment, Root, Crown, Pulp, Root perforations, Furcation perforations, Perforating internal resorptions, External resorption, Root-end filling, Permanent dentine restoration, Temporary dentine-enamel restoration, Biodentine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dental restorative or endodontic treatment requiring Biodentine XP useDevice
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.

Study groups in NCT06955429
Study group	Role	What they receive
Temporary teeth treated in restorative treatment		For temporary teeth treated in restorative treatment arm, the following restoration indications will be found : * In the crown * Permanent dentine restoration (including under composites or Inlay/Onlay) * Enamel restoration for up to 6 months * Restoration of deep and/or large coronal carious lesions * Restoration of cervical or radicular lesions * On the pulp * Direct pulp capping * Indirect pulp capping * Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes Receives: Device: Dental restorative or endodontic treatment requiring Biodentine XP use
Permanent (mature or immature) teeth treated in restorative treatment.		For permanent (mature or immature) teeth treated in restorative treatment arm, the following restoration indications will be found : * In the crown * Permanent dentine restoration (including under composites or Inlay/Onlay) * Temporary dentine-enamel restoration (for up to six-months) * Restoration of deep and/or large coronal carious lesions * Restoration of cervical or radicular lesions * On the pulp * Direct pulp capping * Indirect pulp capping * Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes Receives: Device: Dental restorative or endodontic treatment requiring Biodentine XP use
Permanent (mature or immature teeth) treated in endodontic treatment.		For permanent (mature or immature) teeth treated in endodontic treatment arm, the following endodontic indications will be found : For permanent teeth (immature or mature): * Repair of root perforations * Repair of furcation perforations * Repair of perforating internal resorption * Repair of external resorption * Root-end filling in endodontic surgery (retrograde filling) For immature permanent teeth with necrotic pulp: * Apexification * Revitalization procedure relying on root canal revascularisation. Receives: Device: Dental restorative or endodontic treatment requiring Biodentine XP use

What is being measured

The primary outcome is the main question the study is designed to answer.

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Crown and pulp (restoration) Clinical: No pain, no pulpal symptomatology, no abscesses, no swelling, fistula. Positive response to the pulp vitality electric test.
Radiographic : No radiolucency at the site of treatment \& no wideining of desmodontal space (permanent tooth), Root canal development (permanent immature teeth).
Indications in the root (endodontic) except revitalization Clinical success: No pain, no inflammation, no abscesses, no swelling and/or fistula. Natural motion or mobility ≤ 1mm, Negative periodontal probing (≤ 4 mm) or positive periodontal probing (> 4 mm) Radiographic success: Absence or reduction of radiolucency at the site of treatment.
Indications in the root (endodontic) only for revitalization:
Clinical success: No pain, no abscesses, no swelling and/or fistula, Mobility inferior or equal to the initial situation.
Radiographic success: Absence or reduction of radiolucency at the site of treatment. Root canal development (for permanent immature teeth)
Measured: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.

Secondary outcomes (3)

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Treatment success based on clinical and radiographic criteria identical to primary endpoint.
Measured: 6 months,1 year for temporary teeth; 6 months, 1 year, 2 years and 5 years for permanent (mature or immature) teeth.
Dentin bridge formation presence (only in restorative indications)
Presence of a dentine bridge observed on the radiographic exam (only for restorative indication).
Measured: At 6 months, 1 year, 2 years post treatment with Biodentine™ XP for temporary teeth (based on X-ray done if required). At 6 months, 1 year, 2 years, 5 years and 10 years post-treatment for permanent (mature or immature teeth)
Safety parameters of Biodentine™ XP during the whole duration of the study including the incidence of treatment-emergent adverse events and device deficiencies.
Safety during the study, based on information collected at each visit:
Adverse events, only those at least possible related to Biodentine™ XP as judged by both sponsor and investigator: nature, number, severity, relationship with Biodentine™ XP and follow up.
Biodentine™ XP deficiency: nature, number, severity.
Measured: From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202528 Feb 2037

First posted2 May 2025
Study start23 Oct 2025
Primary completion29 Feb 2032 (estimated)
Study completion28 Feb 2037 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dental Restoration, PermanentStudies 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: Cohort
Time perspective: Prospective
Enrolment: 275 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06955429
Sponsor's protocol ID: BIOD-XP_2024_01
Other IDs: 2024-A01862-45
Acronym: BIOD XP
Status last verified: Apr 2026
First submitted: 25 Apr 2025
Last updated: 6 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Interested in taking part?

Clinical Operations Medical Affairs Department

1 49 76 70 00 ext. +33

clinical-operations@septodont.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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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, Prospective, International and Multicenter Clinical Investigation Measuring the Longterm Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
ClinicalTrials.gov ID: NCT06955429
Acronym / sponsor ID: BIOD XP / BIOD-XP_2024_01
Conditions: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
Keywords: Dentine restoration, Coronal carious lesions, Restoration of cervical lesion, Restoration of radicular lesion, Pulp capping, Pulpotomy, Apexification, Revitalization
Study type: Observational
Recruitment status: Recruiting
Enrolment: 275 participants (estimated)
Lead sponsor: SeptodontIndustry (pharma, biotech, devices)
Collaborators: DOCAPOST, Axonal-Biostatem
Study start: 23 Oct 2025 (actual)
Primary completion: 29 Feb 2032 (estimated)
Study completion: 28 Feb 2037 (estimated)
First posted: 2 May 2025 (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.

Detailed description

This Clinical Investigation is an Observational, Prospective, and Multicenter study. This clinical investigation will take place in several investigational centres in France and Belgium.

This Clinical InvestigatioI is a prospective study: Patients will be treated with the study device (according to its CE-marked Instruction For Use), then followed up.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Temporary teeth treated in restorative treatment	–	Device: Dental restorative or endodontic treatment requiring Biodentine XP useFor temporary teeth treated in restorative treatment arm, the following restoration indications will be found : * In the crown * Permanent dentine restoration (including under composites or Inlay/Onlay) * Enamel restoration for up to 6 months * Restoration of deep and/or large coronal carious lesions * Restoration of cervical or radicular lesions * On the pulp * Direct pulp capping * Indirect pulp capping * Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes
Permanent (mature or immature) teeth treated in restorative treatment.	–	Device: Dental restorative or endodontic treatment requiring Biodentine XP useFor permanent (mature or immature) teeth treated in restorative treatment arm, the following restoration indications will be found : * In the crown * Permanent dentine restoration (including under composites or Inlay/Onlay) * Temporary dentine-enamel restoration (for up to six-months) * Restoration of deep and/or large coronal carious lesions * Restoration of cervical or radicular lesions * On the pulp * Direct pulp capping * Indirect pulp capping * Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes
Permanent (mature or immature teeth) treated in endodontic treatment.	–	Device: Dental restorative or endodontic treatment requiring Biodentine XP useFor permanent (mature or immature) teeth treated in endodontic treatment arm, the following endodontic indications will be found : For permanent teeth (immature or mature): * Repair of root perforations * Repair of furcation perforations * Repair of perforating internal resorption * Repair of external resorption * Root-end filling in endodontic surgery (retrograde filling) For immature permanent teeth with necrotic pulp: * Apexification * Revitalization procedure relying on root canal revascularisation.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Eligible patients are any male and female, adult patients who have undergone one of the following dental treatments using Biodentine™XP respecting the medical device indications.

Key inclusion criteria (3 listed)

Temporary tooth, from a child ≥ 2 years old, requiring dental restorative treatment with Biodentine™ XP, and/or, Permanent (mature or immature) tooth, from a child or an adult, requiring a dental restorative and/or an endodontic treatment with Biodentine™ XP.
Adult patient with a signed informed consent form; For the minor, if in age to understand, an assent is required, and at least one parent or legal representative must consent.
Only in France: Subject affiliated or benefiting from a social/health insurance system.

Key exclusion criteria (9 listed)

Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
Inadequate expected tooth lifetime as estimated by the investigator:
Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
Adult patient under legal protection measures or unable to express his/her consent, and individual deprived of liberty by judicial or administrative decision, as well as individual receiving psychiatric care.
Periodontitis (stage 3, 4 or stage 2 grade C).

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
Dental restorative or endodontic treatment requiring Biodentine XP useIn this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.	Device	Permanent (mature or immature teeth) treated in endodontic treatment., Permanent (mature or immature) teeth treated in restorative treatment., Temporary teeth treated in restorative treatment

Primary outcome

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Time frame: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.
Crown and pulp (restoration) Clinical: No pain, no pulpal symptomatology, no abscesses, no swelling, fistula. Positive response to the pulp vitality electric test. Radiographic : No radiolucency at the site of treatment \& no wideining of desmodontal space (permanent tooth), Root canal development (permanent immature teeth). Indications in the root (endodontic) except revitalization Clinical success: No pain, no inflammation, no abscesses, no swelling and/or fistula. Natural motion or mobility ≤ 1mm, Negative periodontal probing (≤ 4 mm) or positive periodontal probing (> 4 mm) Radiographic success: Absence or reduction of radiolucency at the site of treatment. Indications in the root (endodontic) only for revitalization: Clinical success: No pain, no abscesses, no swelling and/or fistula, Mobility inferior or equal to the initial situation. Radiographic success: Absence or reduction of radiolucency at the site of treatment. Root canal development (for permanent immature teeth)

3 secondary outcomes

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Time frame: 6 months,1 year for temporary teeth; 6 months, 1 year, 2 years and 5 years for permanent (mature or immature) teeth.
Dentin bridge formation presence (only in restorative indications)
Time frame: At 6 months, 1 year, 2 years post treatment with Biodentine™ XP for temporary teeth (based on X-ray done if required). At 6 months, 1 year, 2 years, 5 years and 10 years post-treatment for permanent (mature or immature teeth)
Safety parameters of Biodentine™ XP during the whole duration of the study including the incidence of treatment-emergent adverse events and device deficiencies.
Time frame: From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.

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: Undecided

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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.

Clinical Operations Medical Affairs Department contact

1 49 76 70 00 ext. +33

clinical-operations@septodont.com

Dr Katia Jedeon principal investigator

Hôpital Rotschild

Pr Marjorie Zanini principal investigator

Hôpital Pitié Salpêtrière

Pr Marie-Agnès Gasqui De Saint Joachim principal investigator

Hôpital HCL lyon

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Restoration, Permanent and Dental Restorations, run by Septodont at 8 sites in 2 countries.

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 3 inclusion and 9 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 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 8 sites in France, Belgium. 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?

Contact Clinical Operations Medical Affairs Department (1 49 76 70 00 ext. +33, clinical-operations@septodont.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed (time frame: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.). 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 NCT06955429.

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.