Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

Recruiting

• Conditions: Endodontically Treated Teeth

• Registration Number: NCT05084742
• Lead Sponsor: Septodont

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-20
• Study Start: 2021-11-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2023-12
• Study Completion: 2031-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and radiographic success of treatment	At 10 years post-treatment	The proportion of patients with successfull treatment at 10 years post-surgery will be determined on clinical and radiographic success evidences for each endodontic indication of Biodentine™: * In root end-filling; * In root resorption repair (internal, external); * In root and furcation perforation repair; * In apexification; * In revitalization procedure by means of revascularization

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events (AE) and device deficiencies	From treatment onset to 10 years post-treatment	Safety at 10 years post-surgery will be determined based on the cumulative numbers of Adverse Events (AE) and device deficiencies observed from treatment onset to 10 years post-treatment, for each endodontic indication of Biodentine™: * In root end-filling; * In root resorption repair (internal, external); * In root and furcation perforation repair; * In apexification; * In revitalization procedure by means of revascularization

Trial Locations

Locations (6)

AP-HP, Hôpital Louis Mourier; 🇫🇷 Colombes, France

HCL de Lyon; 🇫🇷 Lyon, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Reims; 🇫🇷 Reims, France

Private dental care office; 🇫🇷 Paris, France

CHU de Toulouse; 🇫🇷 Toulouse, France