Clinical Trials in France / NCT05768295
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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