Prospective_X3: Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants

Sponsor

Anthogyr (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05768295

Collaborator

(none)

200

Enrollment

Arm

51.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Operation Edentulous Jaw Edentulous Mouth Implant	Device: Axiom BL X3	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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-burdensomeaccording 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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Dec 20, 2024

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Axiom BL X3 Dental implant Axiom BL X3	Device: Axiom BL X3 collecting data on the use of Axiom BL X3 and patient satisfaction

Arm

Intervention/Treatment

Other: Axiom BL X3

Dental implant Axiom BL X3

Device: Axiom BL X3

collecting data on the use of Axiom BL X3 and patient satisfaction

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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]
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).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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