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.
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.
Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
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.
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.
Cohort
Prospective
Dental restorative or endodontic treatment requiring Biodentine XP use
DeviceIn this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
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)
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.
Dentin bridge formation presence (only in restorative indications)
Presence of a dentine bridge observed on the radiographic exam (only for restorative indication).
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.
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.
Usability of Biodentine™ XP (all patient subgroups): completion of usability questionnaire by dental surgeons after using Biodentine™ XP and user summary questionnaire (overall satisfaction, …).
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