Clinical trial NCT06955429: Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
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
Biodentine XP
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: Axonal-Biostatem
First posted: 2025-05-02
Enrollment: 275
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
timeFrame: 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:
measure: Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
timeFrame: 6 months,1 year for temporary teeth; 6 months, 1 year, 2 years and 5 years for permanent (mature or immature) teeth.
measure: Dentin bridge formation presence (only in restorative indications)
timeFrame: 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)
measure: Safety parameters of Biodentine™ XP during the whole duration of the study including the incidence of treatment-emergent adverse events and device deficiencies.
timeFrame: From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.
Other outcomes:
measure: Usability parameters of Biodentine™ XP on the whole procedure, assessed by the dental surgeon practitioner immediately after use, will be evaluated using a questionnaire designed for dentists.
timeFrame: At the initiation of the study, at its 6-month, 1-year, 2-year, 3-year, 4-year anniversary and after inclusion of all patients in the study.
Locations:
city: Lyon
country: France
facility: HCL Lyon
city: Nantes
country: France
facility: Cabinet dentaire
city: Paris
country: France
facility: Cabinet dentaire
city: Paris
country: France
facility: Hôpital Rotschild
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Hôpital Rotschild
name: Dr Katia Jedeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Pitié Salpêtrière
name: Pr Marjorie Zanini
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital HCL lyon
name: Pr Marie-Agnès Gasqui De Saint Joachim
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet dentaire
name: Dr. Alexis Gaudin
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Rennes
name: Dr Justine Le Clerc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet dentaire
name: Dr Sandrine DAHAN
role: PRINCIPAL_INVESTIGATOR
References: