Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Post-Market Clinical Follow-Up study aims to document the success and survival of the AxiomĀ® BL X3 Implants up to 3 years after loading.
The total study duration for each patient should be 3 years after loading. .
The investigational devices are CE-(ConformitƩ EuropƩenne, meaning European Conformity) marked product.
14 centers will participate in France
Implants used are AxiomĀ® 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axiom BL X3 | Other | Dental implant Axiom BL X3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axiom BL X3 | Device | collecting data on the use of Axiom BL X3 and patient satisfaction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant success rate | The success rate will be assessed according to the criteria of Buser
| 3 years after loading |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival rate | A surviving implant is an implant that is in place at the time of evaluation | 6, 12 months, and 3 years after loading |
| Prosthesis survival rate | a surviving prosthesis is a prosthesis that is not broken at the time of evaluation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrice Margossian, Dr | Cabinet Dr Margossian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Dentaire Les Aravis | Annecy | France | ||||
| Cabinet Dr Fumery |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| 6, 12 months, and 3 years after loading |
| Prosthesis success rate | Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period. | 6, 12 months, and 3 years after loading |
| Marginal bone level changes | Change in crestal bone level measured by analysis of standardized peri-apical xrays [mm] | 12 months and 3 years after loading |
| Patient Reported Outcome | The local language version of the OHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4). | 6, 12 months, and 3 years after loading |
| Physician satisfaction of the implant stability | Likert scale : The likert scale will be used for consistency and provides five possible answers to a statement or question that allows respondents to indicate their positive-to-negative strength of agreement or strength of feeling regarding the question or statement. | at the time of implant placement |
| Interim Implant success rate | A surviving implant is an implant that is in place at the time of evaluation | 6, 12 months |
| 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-SaƓne | France |
| Cabinet Dr Broda | Villepreux | France |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided