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

Endodontically Treated Teeth Clinical Trial

Official title:

Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084742
• Other study ID #: BIOD2021-03
• Secondary ID: 2021-A01631-40
• Status: Recruiting
• Start date: November 8, 2021
• Est. completion date: September 2031

Study information

• Verified date: November 2023
• Source: Septodont
• Contact: Farid Benabdallah, MD
• Phone: +33 (0)149767328
• Email: fbenabdallah[@]septodont.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2031
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

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.

Locations

Country	Name	City	State
France	AP-HP, Hôpital Louis Mourier	Colombes
France	HCL de Lyon	Lyon
France	CHU de Nantes	Nantes
France	Private dental care office	Paris
France	Private dental care office	Paris
France	Private dental care office	Paris
France	CHU de Reims	Reims
France	CHU de Toulouse	Toulouse

Sponsors (4)

Lead Sponsor	Collaborator
Septodont	EndoData, QualityStat, ReCOL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and radiographic success of 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	At 10 years post-treatment
Secondary	Number of Adverse Events (AE) and device deficiencies	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	From treatment onset to 10 years post-treatment