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NCT Number: NCT05768295

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Surgical Operation Edentulous Jaw Edentulous Mouth Implant Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet Dentaire Les Aravis, Annecy, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axiom BL X3

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Implant survival rate

    Time frame: 6, 12 months, and 3 years after loading

    A surviving implant is an implant that is in place at the time of evaluation

  2. Prosthesis survival rate

    Time frame: 6, 12 months, and 3 years after loading

    a surviving prosthesis is a prosthesis that is not broken at the time of evaluation

  3. Prosthesis success rate

    Time frame: 6, 12 months, and 3 years after loading

    Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period.

  4. Marginal bone level changes

    Time frame: 12 months and 3 years after loading

    Change in crestal bone level measured by analysis of standardized peri-apical xrays [mm]

  5. Patient Reported Outcome

    Time frame: 6, 12 months, and 3 years after loading

    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. Physician satisfaction of the implant stability

    Time frame: at the time of implant placement

    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.

  7. Interim Implant success rate

    Time frame: 6, 12 months

    A surviving implant is an implant that is in place at the time of evaluation

Sponsors and collaborators

Lead sponsor

Anthogyr

Industry

Registry information

Acronym: Prospective_X3

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Mar 14, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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