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

Not Applicable

Active, not recruiting

• Conditions: Edentulous Jaw; Edentulous Mouth; Surgical Operation; Implant
• Interventions: Device: Axiom BL X3

• Registration Number: NCT05768295
• Lead Sponsor: Anthogyr

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.

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-14
• Study Start: 2023-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-08-20
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Axiom BL X3	Axiom BL X3	Dental implant Axiom BL X3

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 \[mm\]
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).
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

Trial Locations

Locations (13)

Cabinet Dentaire Les Aravis; 🇫🇷 Annecy, France

Cabinet Dentaire Patrice Margossian; 🇫🇷 Marseille, France

Cabinet BAG; 🇫🇷 Toulouse, France

Cabinet Dr Vigouroux; 🇫🇷 Cadaujac, France

Implantys; 🇫🇷 Villefranche-sur-Saône, France

Cabinet Dr Fumery; 🇫🇷 Beauvais, France

Cabinet dentaire Octogone; 🇫🇷 Draguignan, France

Cabinet dentaire Dr Murcia; 🇫🇷 Le Bouscat, France

Cabinet Dr Gris; 🇫🇷 Royan, France

Cabinet Dr Broda; 🇫🇷 Villepreux, France

Cabinet Dr Bruet; 🇫🇷 Moulins, France

Cabinet Dr Soriano; 🇫🇷 Saint-Jeoire, France

Cabinet Dr Monnot; 🇫🇷 Sallanches, France