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

NCT06955429 | Recruiting FDA Device

• 2 other identifiers: BIOD-XP_2024_012024-A01862-45
• Study Type: observational
• Target: 275
• Locations: 2 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed

  Crown and pulp (restoration) Clinical: No pain, no pulpal symptomatology, no abscesses, no swelling, fistula. Positive response to the pulp vitality electric test. Radiographic : No radiolucency at the site of treatment \& no wideining of desmodontal space (permanent tooth), Root canal development (permanent immature teeth). Indications in the root (endodontic) except revitalization Clinical success: No pain, no inflammation, no abscesses, no swelling and/or fistula. Natural motion or mobility ≤ 1mm, Negative periodontal probing (≤ 4 mm) or positive periodontal probing (\> 4 mm) Radiographic success: Absence or reduction of radiolucency at the site of treatment. Indications in the root (endodontic) only for revitalization: Clinical success: No pain, no abscesses, no swelling and/or fistula, Mobility inferior or equal to the initial situation. Radiographic success: Absence or reduction of radiolucency at the site of treatment. Root canal development (for permanent immature teeth)

  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 (3)

• Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed

  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)

  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.

  From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.

Other Outcomes (1)

• 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.

  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.

Study Arms (3)

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

Device: Dental restorative or endodontic treatment requiring Biodentine XP use

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

Device: Dental restorative or endodontic treatment requiring Biodentine XP use

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.

Device: Dental restorative or endodontic treatment requiring Biodentine XP use

Interventions

Dental restorative or endodontic treatment requiring Biodentine XP use DEVICE

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DOCAPOST: collaborator
• Septodont: lead
• Axonal-Biostatem: collaborator

Study Sites (8)

Queen Astrid Dental Practice

Kraainem, Belgium

RECRUITING

UZ Leuven - University hospital

Leuven, Belgium

RECRUITING

HCL Lyon

Lyon, 69002, France

RECRUITING

Cabinet dentaire

Nantes, 44093, France

RECRUITING

Cabinet dentaire

Paris, 75008, France

RECRUITING

Hôpital Rotschild

Paris, 75012, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

CHU Rennes

Rennes, 35000, France

RECRUITING

Study Officials

• Dr Katia Jedeon

  Hôpital Rotschild

  PRINCIPAL INVESTIGATOR

• Pr Marjorie Zanini

  Hôpital Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

• Pr Marie-Agnès Gasqui De Saint Joachim

  Hôpital HCL lyon

  PRINCIPAL INVESTIGATOR

• Dr. Alexis Gaudin

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Dr Justine Le Clerc

  CHRU Rennes

  PRINCIPAL INVESTIGATOR

• Dr Sandrine DAHAN

  Cabinet dentaire

  PRINCIPAL INVESTIGATOR

• Pr Joseph Sabbagh, DDS, MSc, PhD, HDR, FICD

  Queen Astrid Dental Practice

  PRINCIPAL INVESTIGATOR

• Pr. Simon Mariano PEDANO DE PIERO, DDS, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Operations Medical Affairs Department

CONTACT

1 49 76 70 00; clinical-operations@septodont.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): February 29, 2032
• Study Completion (Estimated): February 28, 2037
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (6); BE (2)