Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
Conditions
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
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.
Interventions
DEVICEDental 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.
Sponsors
Septodont
DOCAPOST
Axonal-Biostatem
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. | 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. |
Countries
Belgium, France
Contacts
CONTACTClinical Operations Medical Affairs Department
PRINCIPAL_INVESTIGATORDr Katia Jedeon
Hôpital Rotschild
PRINCIPAL_INVESTIGATORPr Marjorie Zanini
Hôpital Pitié Salpêtrière
PRINCIPAL_INVESTIGATORPr Marie-Agnès Gasqui De Saint Joachim
Hôpital HCL lyon
PRINCIPAL_INVESTIGATORDr. Alexis Gaudin
Nantes University Hospital
PRINCIPAL_INVESTIGATORDr Justine Le Clerc
CHRU Rennes
PRINCIPAL_INVESTIGATORDr Sandrine DAHAN
Cabinet dentaire
PRINCIPAL_INVESTIGATORPr Joseph Sabbagh, DDS, MSc, PhD, HDR, FICD
Queen Astrid Dental Practice
PRINCIPAL_INVESTIGATORPr. Simon Mariano PEDANO DE PIERO, DDS, PhD
UZ Leuven
Outcome results
None listed