Clinical trial NCT05084742: Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
Official title: Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endodontically Treated Teeth
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: EndoData
name: Recherche Clinique en Odontologie (ReCOL)
name: QualityStat
First posted: 2021-10-20
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 160 patients with a permanent tooth treated at least 1 year and no more than 5.5 years ago through an endodontic microsurgery using Biodentine™, all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical and radiographic success of treatment
timeFrame: At 10 years post-treatment
Secondary outcomes:
measure: Number of Adverse Events (AE) and device deficiencies
timeFrame: From treatment onset to 10 years post-treatment
Other outcomes:
Locations:
city: Colombes
country: France
facility: AP-HP, Hôpital Louis Mourier
city: Lyon
country: France
facility: HCL de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Private dental care office
city: Paris
country: France
facility: Private dental care office
city: Paris
country: France
facility: Private dental care office
city: Reims
country: France
facility: CHU de Reims
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU de Lyon, France
name: Brigitte Grosgogeat, MD, PhD
role: STUDY_DIRECTOR
affiliation: CHU de Toulouse, France
name: Marie Georgelin Gurgel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Hôpital Louis Mourier, Colombes, France
name: Anne-Margaux Collignon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Nantes, France
name: Alexis Gaudin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCL de Lyon, France
name: Cyril Villat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Reims, France
name: Marie-Paule Gellé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private dental practice, Paris, France
name: Sandrine Dahan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private dental practice, Paris, France
name: Grégory Caron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private dental practice, Paris, France
name: Cauris Couvrechel, MD
role: PRINCIPAL_INVESTIGATOR
References: