Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
- Conditions
- Dental Restoration, PermanentDental RestorationsEndodontic Treatment
- Registration Number
- NCT06955429
- Lead Sponsor
- Septodont
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 275
- 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.
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Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
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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.
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Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
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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.
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Periodontitis (stage 3, 4 or stage 2 grade C).
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Inability to comply with study procedures.
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Participation in another interventional clinical investigation that can induce bias in the study results.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth. 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)
- Secondary Outcome Measures
Name Time Method 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. Treatment success based on clinical and radiographic criteria identical to primary endpoint.
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) 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. From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth. 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.
Trial Locations
- Locations (5)
HCL Lyon
🇫🇷Lyon, France
Cabinet dentaire
🇫🇷Paris, France
Hôpital Rotschild
🇫🇷Paris, France
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France