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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-05

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Operation Edentulous Jaw Edentulous Mouth Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

according to local regulation : The study is an investigation on Medical Device CE marked used in its intended purpose without the objective of CE marking or establishing conformity and with additional procedure non-invasive or non-burdensome

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axiom BL X3

Dental implant Axiom BL X3

Group Type OTHER

Axiom BL X3

Intervention Type DEVICE

collecting data on the use of Axiom BL X3 and patient satisfaction

Interventions

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Axiom BL X3

collecting data on the use of Axiom BL X3 and patient satisfaction

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No