Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
NCT ID: NCT06955429
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
275 participants
OBSERVATIONAL
2025-09-01
2036-07-15
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
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
Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
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.
Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
Interventions
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Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Only in France: Subject affiliated or benefiting from a social/health insurance system.
Exclusion Criteria
2. 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.
3. Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
4. 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.
5. Periodontitis (stage 3, 4 or stage 2 grade C).
6. Inability to comply with study procedures.
7. Participation in another interventional clinical investigation that can induce bias in the study results.
2 Years
ALL
No
Sponsors
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Axonal-Biostatem
INDUSTRY
Septodont
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Katia Jedeon
Role: PRINCIPAL_INVESTIGATOR
Hôpital Rotschild
Pr Marjorie Zanini
Role: PRINCIPAL_INVESTIGATOR
Hôpital Pitié Salpêtrière
Pr Marie-Agnès Gasqui De Saint Joachim
Role: PRINCIPAL_INVESTIGATOR
Hôpital HCL lyon
Dr. Alexis Gaudin
Role: PRINCIPAL_INVESTIGATOR
Cabinet dentaire
Dr Justine Le Clerc
Role: PRINCIPAL_INVESTIGATOR
CHRU Rennes
Dr Sandrine DAHAN
Role: PRINCIPAL_INVESTIGATOR
Cabinet dentaire
Locations
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HCL Lyon
Lyon, , France
Cabinet dentaire
Nantes, , France
Cabinet dentaire
Paris, , France
Hôpital Rotschild
Paris, , France
Hôpital Pitié Salpêtrière
Paris, , France
CHU Rennes
Rennes, , France
Countries
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Central Contacts
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Other Identifiers
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2024-A01862-45
Identifier Type: OTHER
Identifier Source: secondary_id
BIOD-XP_2024_01
Identifier Type: -
Identifier Source: org_study_id
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