Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants (Prospective_X3)

Anthogyr

Status: Active, not recruiting

Conditions: Surgical Operation; Edentulous Jaw; Edentulous Mouth; Implant

Treatments: Device: Axiom BL X3

Study type: Interventional

Funder types: Industry

Identifiers

NCT05768295

C2101

Details and patient eligibility

About

This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.

Full description

The total study duration for each patient should be 3 years after loading. .

The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product.

14 centers will participate in France

Implants used are Axiom® BL X3 with lengths ranging from 6.5 to 18 mm and diameters ranging from 3.4 to 6.4 mm.

The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155, 21CFR 820 for FDA requirement and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must provide their informed consent for study participation and must be willing and able to attend control visit (in the standard of care)
• Patients must be males or females who are a minimum of 18 years of age
• Patients seeking an implant supported restoration
• Patient Affiliated to (or beneficiary of) the French Social Security
• Patients who do not present any contraindication for implant restoration, in accordance to IFU

Exclusion criteria

• Patients who have no follow-up visit planned with the investigator or co-investigators
• Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance with study visit or unreliability
• A woman who is pregnant or planning to become pregnant at any point during the study duration
• Patients currently participating in another clinical research
• Patients who present contraindication for implant restoration, in accordance to IFU
• Adults under guardianship

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Axiom BL X3

Other group

Description:

Dental implant Axiom BL X3

Treatment:

Device: Axiom BL X3