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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01862-45 | Other Identifier | ANSM, BIOLOGICAL RESEARCH AND COLLECTIONS (BRC) |
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| Name | Class |
|---|---|
| DOCAPOST | UNKNOWN |
| Axonal-Biostatem | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporary teeth treated in restorative treatment | For temporary teeth treated in restorative treatment arm, the following restoration indications will be found :
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| 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 :
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| 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):
For immature permanent teeth with necrotic pulp:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, …). | 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. |
Inclusion Criteria:
Exclusion Criteria:
Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
Inadequate expected tooth lifetime as estimated by the investigator:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Medical Affairs Department | Contact | 1 49 76 70 00 | +33 | clinical-operations@septodont.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Katia Jedeon | Hôpital Rotschild | Principal Investigator |
| Pr Marjorie Zanini | Hôpital Pitié Salpêtrière | Principal Investigator |
| Pr Marie-Agnès Gasqui De Saint Joachim |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Astrid Dental Practice | Recruiting | Kraainem | Belgium | |||
| UZ Leuven - University hospital |
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| 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. |
| 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 |
| Recruiting |
| Leuven |
| Belgium |
| HCL Lyon | Recruiting | Lyon | 69002 | France |
| Cabinet dentaire | Recruiting | Nantes | 44093 | France |
| Cabinet dentaire | Recruiting | Paris | 75008 | France |
| Hôpital Rotschild | Recruiting | Paris | 75012 | France |
| Hôpital Pitié Salpêtrière | Recruiting | Paris | 75013 | France |
| CHU Rennes | Recruiting | Rennes | 35000 | France |