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

Septodont

Status: Begins enrollment in 2 months

Conditions: Dental Restorations; Endodontic Treatment; Dental Restoration, Permanent

Treatments: Device: Dental restorative or endodontic treatment requiring Biodentine XP use

Study type: Observational

Funder types: Industry

Identifiers

NCT06955429

2024-A01862-45 (Other Identifier)

BIOD-XP_2024_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 275 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

275 participants in 3 patient groups

Temporary teeth treated in restorative treatment

Description:

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

Treatment:

Device: Dental restorative or endodontic treatment requiring Biodentine XP use

Permanent (mature or immature) teeth treated in restorative treatment.

Description:

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

Treatment:

Device: Dental restorative or endodontic treatment requiring Biodentine XP use

Permanent (mature or immature teeth) treated in endodontic treatment.

Description:

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.

Treatment:

Device: Dental restorative or endodontic treatment requiring Biodentine XP use