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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768295
Other study ID # C2101
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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