NCT05768295

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Apr 2023Jul 2027

First Submitted

Initial submission to the registry

January 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

January 27, 2023

Last Update Submit

March 17, 2025

Conditions

Surgical OperationEdentulous JawEdentulous MouthImplant

Keywords

survival ratesuccess rateAnthogyrAxiom® BL X3

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Implant survival rate

    6, 12 months, and 3 years after loading

  • Prosthesis survival rate

    6, 12 months, and 3 years after loading

  • Prosthesis success rate

    6, 12 months, and 3 years after loading

  • Marginal bone level changes

    12 months and 3 years after loading

  • Patient Reported Outcome

    6, 12 months, and 3 years after loading

  • +2 more secondary outcomes

Study Arms (1)

Axiom BL X3

OTHER

Dental implant Axiom BL X3

Device: Axiom BL X3

Interventions

Axiom BL X3DEVICE

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

Axiom BL X3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cabinet Dentaire Les Aravis

Annecy, France

Location

Cabinet Dr Fumery

Beauvais, France

Location

Cabinet Dr Vigouroux

Cadaujac, France

Location

Cabinet dentaire Octogone

Draguignan, France

Location

Cabinet dentaire Dr Murcia

Le Bouscat, France

Location

Cabinet Dentaire Patrice Margossian

Marseille, France

Location

Cabinet Dr Bruet

Moulins, France

Location

Cabinet Dr Gris

Royan, France

Location

Cabinet Dr Soriano

Saint-Jeoire, France

Location

Cabinet Dr Monnot

Sallanches, France

Location

Cabinet BAG

Toulouse, France

Location

Implantys

Villefranche-sur-Saône, France

Location

Cabinet Dr Broda

Villepreux, France

Location

MeSH Terms

Conditions

Jaw, EdentulousMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Study Officials

  • Patrice Margossian, Dr

    Cabinet Dr Margossian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

March 14, 2023

Study Start

April 5, 2023

Primary Completion

August 20, 2025

Study Completion (Estimated)

July 1, 2027

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)