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

NCT05768295•Anthogyr

Summary

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (13)

Cabinet Dentaire Les Aravis

Annecy, France

Cabinet Dr Fumery

Beauvais, France

Cabinet Dr Vigouroux

Cadaujac, France

Cabinet dentaire Octogone

Draguignan, France

Cabinet dentaire Dr Murcia

Le Bouscat, France

Cabinet Dentaire Patrice Margossian

Marseille, France

Cabinet Dr Bruet

Moulins, France

Cabinet Dr Gris

Royan, France

Cabinet Dr Soriano

Saint-Jeoire, France

Cabinet Dr Monnot

Sallanches, France

Key Dates

Start Date

April 5, 2023

Primary Completion Date

August 20, 2025

Completion Date

July 1, 2027

Last Updated

March 19, 2025

Enrollment

200

ESTIMATED participants

Conditions

Surgical OperationEdentulous JawEdentulous MouthImplant

Interventions

Axiom BL X3

DEVICE

Primary Stability and Peri-implant Outcomes of Short Implants in Post-extraction Single-tooth Sites

NCT07177521

Edentulous JawTooth Loss+1 more

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COMPLETEDNA

Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology

NCT07369583

Edentulous Jaw

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Primary Stability and Peri-implant Outcomes of Short Implants in Post-extraction Single-tooth Sites

Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology

Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.

Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study

Effect of Digital Versus Static Jaw Relation Record on Crestal Bone Changes Around Implants Supporting Maxillary Single Overdenture

Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics