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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant

Intervention / Treatment
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* Device: Axiom BL X3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Axiom BL X3<br>Dental implant Axiom BL X3 | Device: Axiom BL X3<br>* collecting data on the use of Axiom BL X3 and patient satisfaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant success rate | 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 | 3 years after loading | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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survival rate, success rate, Anthogyr, Axiom® BL X3