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Active, not recruiting Not applicable

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

NCT05768295 · tracked via the Priya Life Science France tracker
Sponsor
Anthogyr
Phase
Not applicable
Started
2023-04-05
Last updated
2025-03-19

Condition(s) studied

Surgical OperationEdentulous JawEdentulous MouthImplant

Investigational drug(s) / intervention(s)

Axiom BL X3

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Implant success rate — 3 years after loading
    The success rate will be assessed according to the criteria of Buser * no detectable clinical mobility (hand testing) * no radiolucency surrounding the total surface of the implant * no persistent pain refractory to medical therapy * no recurrent peri-implant infection

Trial sites (13)

FacilityCityRegionStatus
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
Cabinet BAG Toulouse France
Implantys Villefranche-sur-Saône France
Cabinet Dr Broda Villepreux France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05768295 on ClinicalTrials.gov ↗ ← All trials in France