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

Edentulous Jaw Clinical Trial

— Prospective_X3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768295
• Other study ID #: C2101
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: July 2027

Study information

• Verified date: April 2023
• Source: Anthogyr
• Contact: Marie Chauvet
• Phone: +33 (0)4 50 58 02 37
• Email: marie.chauvet[@]anthogyr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2027
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Implant
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

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

Locations

Country	Name	City	State
France	Cabinet Dentaire Les Aravis	Annecy
France	Cabinet Dr Fumery	Beauvais
France	Cabinet Dr Vigouroux	Cadaujac
France	Cabinet dentaire Octogone	Draguignan
France	Cabinet dentaire La Bastide	L'Isle-sur-la-Sorgue
France	Cabinet dentaire Dr Murcia	Le Bouscat
France	Cabinet Dentaire Patrice Margossian	Marseille
France	Cabinet Dr Bruet	Moulins
France	Cabinet Dr Monnot	Sallanches
France	Cabinet BAG	Toulouse
France	Implantys	Villefranche-sur-Saône

Sponsors (1)

Lead Sponsor	Collaborator
Anthogyr

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Interim Implant success rate	A surviving implant is an implant that is in place at the time of evaluation	6, 12 months