Edentulous Jaw, Edentulous Mouth, Implant, Surgical Operation
Conditions
Keywords
survival rate, success rate, Anthogyr, Axiom® BL X3
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.
Interventions
DEVICEAxiom BL X3
collecting data on the use of Axiom BL X3 and patient satisfaction
Sponsors
Anthogyr
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthesis survival rate | 6, 12 months, and 3 years after loading | a surviving prosthesis is a prosthesis that is not broken at the time of evaluation |
| Prosthesis success rate | 6, 12 months, and 3 years after loading | Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period. |
| Marginal bone level changes | 12 months and 3 years after loading | Change in crestal bone level measured by analysis of standardized peri-apical xrays \[mm\] |
| Implant survival rate | 6, 12 months, and 3 years after loading | A surviving implant is an implant that is in place at the time of evaluation |
| Physician satisfaction of the implant stability | at the time of implant placement | 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. |
| Interim Implant success rate | 6, 12 months | A surviving implant is an implant that is in place at the time of evaluation |
| Patient Reported Outcome | 6, 12 months, and 3 years after loading | 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). |
Countries
France
Outcome results
None listed