NCT06955429

Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

Observational, Prospective, International and Multicenter Clinical Investigation Measuring the Longterm Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 275 (estimated)
• Sponsor: Septodont · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Restoration, Permanent
• Dental Restorations
• Endodontic Treatment

Interventions

Type	Name	Description
DEVICE	Dental 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2036-07-15
• Completion: 2036-07-15
• First posted: 2025-05-02
• Last updated: 2025-05-25

Locations

6 sites across 1 country: France

Regulatory

• FDA-regulated device study