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

N/AActive Not RecruitingNCT05768295

Anthogyr200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Surgical Operation Edentulous Jaw Edentulous Mouth Implant

Interventions

Axiom BL X3DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Cabinet Dentaire Les Aravis

Annecy, France

Cabinet Dr Fumery

Beauvais, France

Cabinet Dr Vigouroux

Cadaujac, France

Cabinet dentaire Octogone

Outcomes

Primary Outcomes

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

Time frame: 3 years after loading

Secondary Outcomes

Implant survival rate

A surviving implant is an implant that is in place at the time of evaluation

Time frame: 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

Time frame: 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.

Time frame: 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 \[mm\]

Time frame: 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).

Data from ClinicalTrials.gov

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