Actively Recruiting
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Led by Septodont · Updated on 2026-05-06
275
Participants Needed
8
Research Sites
592 weeks
Total Duration
On this page
Sponsors
S
Septodont
Lead Sponsor
D
DOCAPOST
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Temporary tooth from a child 2 years or older needing dental restorative treatment with Biodentine17 XP, or permanent (mature or immature) tooth from a child or adult needing restorative or endodontic treatment with Biodentine17 XP
- Adult patients with signed informed consent; minors able to understand must assent, and at least one parent or legal representative must consent
- In France only: subject must be affiliated with or benefit from a social or health insurance system
You will not qualify if you...
- Patients with documented contraindications to using Biodentine17 XP
- Expected tooth lifetime too short: high chance of losing a temporary tooth within 2 years or a permanent tooth within 10 years after treatment
- Patients with systemic diseases that may impair healing or follow-up
- Adults under legal protection, unable to consent, deprived of liberty by legal decision, or receiving psychiatric care
- Patients with periodontitis stage 3, 4, or stage 2 grade C
- Patients unable to comply with study procedures
- Participation in another interventional clinical trial that could bias results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Queen Astrid Dental Practice
Kraainem, Belgium
Actively Recruiting
2
UZ Leuven - University hospital
Leuven, Belgium
Actively Recruiting
3
HCL Lyon
Lyon, France, 69002
Actively Recruiting
4
Cabinet dentaire
Nantes, France, 44093
Actively Recruiting
5
Cabinet dentaire
Paris, France, 75008
Actively Recruiting
6
Hôpital Rotschild
Paris, France, 75012
Actively Recruiting
7
Hôpital Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
8
CHU Rennes
Rennes, France, 35000
Actively Recruiting
Research Team
C
Clinical Operations Medical Affairs Department
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here