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NCT06955429 | NOT YET RECRUITING | Dental Restoration, Permanent

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

Septodont

Brief 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.

Condition or disease

Dental Restoration, Permanent

Dental Restorations

Endodontic Treatment

Intervention/treatment

Dental restorative or endodontic treatment requiring Biodentine XP use

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 275 participants
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.
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2036-07-15
Estimated Study Completion Date : 2036-07-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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.
  • 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
  • 1. Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
  • 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.
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

Location Details

NCT06955429

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

HCL Lyon

Lyon, France, 69002

Not yet recruiting

France,

Dental office

Nantes, France, 44093

Not yet recruiting

France,

Dental office

Paris, France, 75008

Not yet recruiting

France,

Hôpital Rotschild

Paris, France, 75012

Not yet recruiting

France,

Salpêtrière Pitié Hospital

Paris, France, 75013

Not yet recruiting

France,

Rinses

Rennes, France, 35000