Evaluating the long-term safety and performance of Biodentine™ in dental treatments
Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
This study is testing how safe and effective Biodentine™, a dental material used in root treatments, is for patients over a 10-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Sex | All |
| Sponsor | Septodont Industry-sponsored |
| Locations | 8 sites (Colombes and 7 other locations) |
| Trial ID | NCT05084742 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the long-term performance and safety of Biodentine™, a dental material used in various endodontic procedures, over a 10-year period. It involves a multicenter follow-up of patients who have undergone treatments such as root-end filling and apexification using Biodentine™. Data will be collected through clinical examinations and radiographic evaluations to determine the material's effectiveness and safety in dental applications.
Who should consider this trial
Good fit: Ideal candidates include adults and children with permanent teeth that have undergone endodontic treatment using Biodentine™ within the specified time frame.
Not a fit: Patients who have undergone anti-cancer therapy in the last five years or have uncontrolled systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term reliability and safety of Biodentine™, potentially improving dental treatment outcomes.
How similar studies have performed: While similar studies have evaluated dental materials, this specific long-term observational approach for Biodentine™ is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, adult or child with permanent study tooth (immature or mature) * Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification * Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit * Availability of baseline radiographic image of the study tooth * Patient affiliated to national health insurance * Patient informed about the study and who confirms his/her consent to participate to the study Exclusion Criteria: * Patient treated with anti-cancer therapy in the 5 years prior to the treatment * Uncontrolled systemic disease 1 month prior to the treatment * Development of a cancer or a systemic disease just after the treatment * Participation to an interventional clinical trial at the time of the treatment
Where this trial is running
Colombes and 7 other locations
- AP-HP, Hôpital Louis Mourier — Colombes, France (Recruiting)
- HCL de Lyon — Lyon, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- Private dental care office — Paris, France (Recruiting)
- Private dental care office — Paris, France (Recruiting)
- Private dental care office — Paris, France (Recruiting)
- CHU de Reims — Reims, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Marie Georgelin Gurgel, MD — CHU de Toulouse, France
- Study coordinator: Farid Benabdallah, MD
- Email: fbenabdallah@septodont.com
- Phone: +33 (0)149767328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.