Trials / Recruiting
RecruitingNCT05084742
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (estimated)
- Sponsor
- Septodont · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed: * Repair of root or furcation perforations. * Repair of root resorptions (internal and external). * Root-end filling in endodontic surgery (retrograde filling). * Apexification (tooth with open apex). * Revitalization procedure by means of revascularization. Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biodentine™ | Biodentine™ is a bioactive dentin substitute from the " Active Biosilicate Technology® " innovation. Study participants were treated from 1 year to 5,5 years ago through an endodontic microsurgery using Biodentine™ used in its endodontic indications, i.e., root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization. |
Timeline
- Start date
- 2021-11-08
- Primary completion
- 2023-12-01
- Completion
- 2031-09-01
- First posted
- 2021-10-20
- Last updated
- 2023-11-29
Locations
8 sites across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05084742. Inclusion in this directory is not an endorsement.