Clinical trial NCT05768295: Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
Official title: Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Operation
Edentulous Jaw
Edentulous Mouth
Implant
Keywords: survival rate
success rate
Anthogyr
Axiom® BL X3
Lead sponsor: Anthogyr
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Implant success rate
timeFrame: 3 years after loading
Secondary outcomes:
measure: Implant survival rate
timeFrame: 6, 12 months, and 3 years after loading
measure: Prosthesis survival rate
timeFrame: 6, 12 months, and 3 years after loading
measure: Prosthesis success rate
timeFrame: 6, 12 months, and 3 years after loading
measure: Marginal bone level changes
timeFrame: 12 months and 3 years after loading
measure: Patient Reported Outcome
timeFrame: 6, 12 months, and 3 years after loading
measure: Physician satisfaction of the implant stability
timeFrame: at the time of implant placement
measure: Interim Implant success rate
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Cabinet Dentaire Les Aravis
city: Beauvais
country: France
facility: Cabinet Dr Fumery
city: Cadaujac
country: France
facility: Cabinet Dr Vigouroux
city: Draguignan
country: France
facility: Cabinet dentaire Octogone
city: Le Bouscat
country: France
facility: Cabinet dentaire Dr Murcia
city: Marseille
country: France
facility: Cabinet Dentaire Patrice Margossian
city: Moulins
country: France
facility: Cabinet Dr Bruet
city: Royan
country: France
facility: Cabinet Dr Gris
city: Saint-Jeoire
country: France
facility: Cabinet Dr Soriano
city: Sallanches
country: France
facility: Cabinet Dr Monnot
city: Toulouse
country: France
facility: Cabinet BAG
city: Villefranche-sur-Saône
country: France
facility: Implantys
city: Villepreux
country: France
facility: Cabinet Dr Broda
Study officials:
affiliation: Cabinet Dr Margossian
name: Patrice Margossian, Dr
role: PRINCIPAL_INVESTIGATOR
References: