Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental restorative or endodontic treatment requiring Biodentine XP use.
- Who it may be relevant to
- Registry conditions: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
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.
Interventions
- Device 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.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 6 centers
- HCL Lyon — Lyon
- Cabinet dentaire — Nantes
- Cabinet dentaire — Paris
- Hôpital Rotschild — Paris
- Hôpital Pitié Salpêtrière — Paris
- CHU Rennes — Rennes
Belgium · 2 centers
- Queen Astrid Dental Practice — Kraainem
- UZ Leuven - University hospital — Leuven
Identifiers
NCT: NCT06955429 · BIOD-XP_2024_01 · 2024-A01862-45