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

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.

Study Overview

• Status: Recruiting
• Conditions: Implant; Edentulous Jaw; Edentulous Mouth; Surgical Operation
• Intervention / Treatment: Device: Axiom BL X3

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Chauvet; Phone Number: +33 (0)4 50 58 02 37; Email: marie.chauvet@anthogyr.com
• Study Contact Backup: Name: Nicolas Courtois; Phone Number: +33 (0)4 50 58 02 37; Email: nicolas.courtois@anthogyr.com

Study Locations

• France
  • Annecy, France
    • Recruiting
    • Cabinet Dentaire Les Aravis
    • Principal Investigator: Nicolas Jung, Dr
    • Sub-Investigator: Jean-Luc Lescure, Dr
  • Beauvais, France
    • Recruiting
    • Cabinet Dr Fumery
    • Principal Investigator: Océan Fumery, Dr
  • Cadaujac, France
    • Recruiting
    • Cabinet Dr Vigouroux
    • Principal Investigator: François Vigouroux, Dr
  • Draguignan, France
    • Recruiting
    • Cabinet dentaire Octogone
    • Principal Investigator: Adrien Sette, Dr
    • Sub-Investigator: Julien Sette, Dr
  • L'Isle-sur-la-Sorgue, France
    • Recruiting
    • Cabinet dentaire La Bastide
    • Principal Investigator: Remy Latombe, Dr
  • Le Bouscat, France
    • Recruiting
    • Cabinet dentaire Dr Murcia
    • Principal Investigator: Jonathan Murcia, Dr
  • Marseille, France
    • Recruiting
    • Cabinet Dentaire Patrice Margossian
    • Principal Investigator: Patrice Margossian, Dr
    • Sub-Investigator: Emilie Goemaere, Dr
  • Moulins, France
    • Recruiting
    • Cabinet Dr Bruet
    • Principal Investigator: Pierre Bruet, Dr
  • Sallanches, France
    • Recruiting
    • Cabinet Dr Monnot
    • Principal Investigator: Chloé Monnot, Dr
  • Toulouse, France
    • Recruiting
    • Cabinet BAG
    • Principal Investigator: Philippe Boghanim, Dr
  • Villefranche-sur-Saône, France
    • Recruiting
    • Implantys
    • Principal Investigator: Harmik Minassian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anthogyr
• Investigators: Principal Investigator: Patrice Margossian, Dr, Cabinet Dr Margossian

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Anticipated): December 20, 2024
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: survival rate; success rate; Anthogyr; Axiom® BL X3
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: C2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No