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De klinische studie NCT06955429 (BIOD XP) voor Dental Restoration, Permanent, Dental Restorations, Endodontische behandeling is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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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)

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De klinische studie NCT06955429 (BIOD XP) is een observationeel studie bij Dental Restoration, Permanent, Dental Restorations, Endodontische behandeling met de status nog niet rekruterend. De inclusie van 275 deelnemers start op 1 september 2025. De studie wordt geleid door Septodont en de voltooiing is gepland op 15 juli 2036. Laatste update op ClinicalTrials.gov: 25 mei 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.

Officiële titel

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.

Aandoeningen
Dental Restoration, PermanentDental RestorationsEndodontische behandeling
Andere studie-ID's
  • BIOD XP
  • BIOD-XP_2024_01
  • 2024-A01862-45 (Overige identificatiecode) (ANSM, BIOLOGICAL RESEARCH AND COLLECTIONS (BRC))
NCT-ID
NCT06955429
Startdatum (Werkelijk)
2025-09-01
Laatste update geplaatst
2025-05-25
Verwachte einddatum
2036-07-15
Inschrijving (Geschat)
275
Studietype
Observationeel
Status
Nog niet rekruterend
Trefwoorden
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
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
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
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.
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
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.
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.
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.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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.
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Treatment success based on clinical and radiographic criteria identical to primary endpoint.
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)
Presence of a dentine bridge observed on the radiographic exam (only for restorative indication).
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.
Safety during the study, based on information collected at each visit: Adverse events, only those at least possible related to Biodentine™ XP as judged by both sponsor and investigator: nature, number, severity, relationship with Biodentine™ XP and follow up. Biodentine™ XP deficiency: nature, number, severity.
From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
2 Years
Geslachten die in aanmerking komen voor de studie
Allen
  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.

  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.

Septodont logoSeptodont
Axonal-Biostatem logoAxonal-Biostatem
Centraal Contactpersoon
Contact: Farid BENABDALLAH, .MD, PhD, 1 49 76 70 00, [email protected]
6 Studielocaties in 1 landen
HCL Lyon, Lyon, 69002, France
Cabinet dentaire, Nantes, 44093, France
Cabinet dentaire, Paris, 75008, France
Hôpital Rotschild, Paris, 75012, France
Hôpital Pitié Salpêtrière, Paris, 75013, France
CHU Rennes, Rennes, 35000, France