Back to resultsMulticentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants (Prospective_X3)
Primary Purpose
Surgical Operation, Edentulous Jaw, Edentulous Mouth
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Axiom BL X3
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Operation focused on measuring survival rate, success rate, Anthogyr, Axiom® BL X3
Eligibility Criteria
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
Sites / Locations
- Cabinet Dentaire Les AravisRecruiting
- Cabinet Dr FumeryRecruiting
- Cabinet Dr VigourouxRecruiting
- Cabinet dentaire OctogoneRecruiting
- Cabinet dentaire La BastideRecruiting
- Cabinet dentaire Dr MurciaRecruiting
- Cabinet Dentaire Patrice MargossianRecruiting
- Cabinet Dr BruetRecruiting
- Cabinet Dr MonnotRecruiting
- Cabinet BAGRecruiting
- ImplantysRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Axiom BL X3
Arm Description
Dental implant Axiom BL X3
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Implant survival rate
A surviving implant is an implant that is in place at the time of evaluation
Prosthesis survival rate
a surviving prosthesis is a prosthesis that is not broken at the time of evaluation
Prosthesis success rate
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
Change in crestal bone level measured by analysis of standardized peri-apical xrays [mm]
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).
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.
Interim Implant success rate
A surviving implant is an implant that is in place at the time of evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05768295
Brief Title
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
Acronym
Prospective_X3
Official Title
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthogyr
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant
Keywords
survival rate, success rate, Anthogyr, Axiom® BL X3
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Axiom BL X3
Arm Type
Other
Arm Description
Dental implant Axiom BL X3
Intervention Type
Device
Intervention Name(s)
Axiom BL X3
Intervention Description
collecting data on the use of Axiom BL X3 and patient satisfaction
Primary Outcome Measure Information:
Title
Implant success rate
Description
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 Outcome Measure Information:
Title
Implant survival rate
Description
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
Title
Prosthesis survival rate
Description
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
Title
Prosthesis success rate
Description
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
Title
Marginal bone level changes
Description
Change in crestal bone level measured by analysis of standardized peri-apical xrays [mm]
Time Frame
12 months and 3 years after loading
Title
Patient Reported Outcome
Description
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).
Time Frame
6, 12 months, and 3 years after loading
Title
Physician satisfaction of the implant stability
Description
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.
Time Frame
at the time of implant placement
Title
Interim Implant success rate
Description
A surviving implant is an implant that is in place at the time of evaluation
Time Frame
6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Chauvet
Phone
+33 (0)4 50 58 02 37
Email
marie.chauvet@anthogyr.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Courtois
Phone
+33 (0)4 50 58 02 37
Email
nicolas.courtois@anthogyr.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Margossian, Dr
Organizational Affiliation
Cabinet Dr Margossian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet Dentaire Les Aravis
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Jung, Dr
First Name & Middle Initial & Last Name & Degree
Jean-Luc Lescure, Dr
Facility Name
Cabinet Dr Fumery
City
Beauvais
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Océan Fumery, Dr
Facility Name
Cabinet Dr Vigouroux
City
Cadaujac
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Vigouroux, Dr
Facility Name
Cabinet dentaire Octogone
City
Draguignan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien Sette, Dr
First Name & Middle Initial & Last Name & Degree
Julien Sette, Dr
Facility Name
Cabinet dentaire La Bastide
City
L'Isle-sur-la-Sorgue
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remy Latombe, Dr
Facility Name
Cabinet dentaire Dr Murcia
City
Le Bouscat
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Murcia, Dr
Facility Name
Cabinet Dentaire Patrice Margossian
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Margossian, Dr
First Name & Middle Initial & Last Name & Degree
Emilie Goemaere, Dr
Facility Name
Cabinet Dr Bruet
City
Moulins
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bruet, Dr
Facility Name
Cabinet Dr Monnot
City
Sallanches
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloé Monnot, Dr
Facility Name
Cabinet BAG
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Boghanim, Dr
Facility Name
Implantys
City
Villefranche-sur-Saône
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harmik Minassian
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
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