Surgical OperationProspective_X3NCT05768295
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
A study testing Axiom BL X3 in people with Surgical Operation and Edentulous Jaw, run by Anthogyr at 13 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Operation, Edentulous Jaw, Edentulous Mouth
- What is being tested?
- Axiom BL X3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesFrance
- Study dates
- 5 Apr 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Cabinet Dentaire Les Aravis
Annecy
Cabinet Dr Fumery
Beauvais
Cabinet Dr Vigouroux
Cadaujac
Cabinet dentaire Octogone
Draguignan
Cabinet dentaire Dr Murcia
Le Bouscat
Cabinet Dentaire Patrice Margossian
Marseille
Cabinet Dr Bruet
Moulins
Cabinet Dr Gris
Royan
Cabinet Dr Soriano
Saint-Jeoire
Cabinet Dr Monnot
Sallanches
Cabinet BAG
Toulouse
Implantys
Villefranche-sur-Saône
Cabinet Dr Broda
Villepreux
About this study
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.
Read the 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.
- Conditions
- Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant
- Being tested
- Axiom BL X3
- Keywords
- survival rate, success rate, Anthogyr, Axiom® BL X3
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axiom BL X3Device
collecting data on the use of Axiom BL X3 and patient satisfaction
| Study group | Role | What they receive |
|---|---|---|
| Axiom BL X3 | Other | Dental implant Axiom BL X3 Receives: Device: Axiom BL X3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years after loading
Secondary outcomes (7)
Implant survival rate
A surviving implant is an implant that is in place at the time of evaluation
Measured: 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
Measured: 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.
Measured: 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]
Measured: 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).
Measured: 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.
Measured: 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
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start5 Apr 2023
- Primary completion20 Aug 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical OperationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthogyr
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Margossian, Dr, Principal investigator, Cabinet Dr Margossian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768295
- Sponsor's protocol ID
- C2101
- Acronym
- Prospective_X3
- Status last verified
- Mar 2025
- First submitted
- 27 Jan 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
- ClinicalTrials.gov ID
- NCT05768295
- Acronym / sponsor ID
- Prospective_X3 / C2101
- Conditions
- Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant
- Keywords
- survival rate, success rate, Anthogyr, Axiom® BL X3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AnthogyrIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Axiom BL X3 | Other | Device: Axiom BL X3Dental implant Axiom BL X3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axiom BL X3collecting data on the use of Axiom BL X3 and patient satisfaction | Device | Axiom BL X3 |
Primary outcome
Implant success rate
Time frame: 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
7 secondary outcomes
Implant survival rate
Time frame: 6, 12 months, and 3 years after loading
Prosthesis survival rate
Time frame: 6, 12 months, and 3 years after loading
Prosthesis success rate
Time frame: 6, 12 months, and 3 years after loading
Marginal bone level changes
Time frame: 12 months and 3 years after loading
Patient Reported Outcome
Time frame: 6, 12 months, and 3 years after loading
Physician satisfaction of the implant stability
Time frame: at the time of implant placement
Interim Implant success rate
Time frame: 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Margossian, Dr principal investigator
Cabinet Dr Margossian
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axiom BL X3 in people with Surgical Operation and Edentulous Jaw, run by Anthogyr at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success rate (time frame: 3 years after loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.