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Clinical Trials in France / NCT04984486
Active, not recruiting Observational

In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Bone Level

NCT04984486 · tracked via the Priya Life Science France tracker
Sponsor
Sudimplant SAS - Groupe TBR
Phase
Observational
Started
2021-09-27
Last updated
2024-04-26

Condition(s) studied

Edentulous

Investigational drug(s) / intervention(s)

dental implant

dental implant: The procedure used to accomplish its intended use is as follows : * The recipient implant site is prepared using a drilling sequence, then the implant is placed at the crestal level * After a period of osseointegration of the implant, a transgingival healing screw is placed to allow the healing of soft tissues. After this healing phase, the final prosthesis will be loaded on the implant.

Study summary

Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically.

TBR® Bone Level Implants allow the patient to prevent bone resorption and maintain facial tissue and musculature support. At the functional level, the patient who benefits from implant treatment regains normal masticatory function with all the benefits on the quality of life that this can bring him.

Due to the osseointegration of the implant and the biocompatibility of the materials used, the implant treatment remains effective in the long term and makes it possible to maintain the aesthetics of the smile.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient 18 years of age or older * Patient who has completed bone growth * Patient informed and willing to participate in the study * Partially or totally toothless patient who will be implanted with the TBR® Bone Level implant(s) for the prospective cohort * Patient implanted with the TBR® Bone Level implant(s) before June 2011 for the retrospective cohort Exclusion Criteria: * Pregnant or lactating women * Patient with bone disease of the head and neck region * Patient refusing to participate in the study * Patient with at least one contraindication to implantation * Patient on osteoporosis treatment with Biphosphonates or Denosumab.

Primary outcome measure(s)

  • the success rate of tissue integration of the implant — 15 years after implantation
    Integration of the implant 15 years after implantation

Trial sites (1)

FacilityCityRegionStatus
Cabinet du Dr ALLOUCHE Montpellier France

More Sudimplant SAS - Groupe TBR trials in France

In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1 Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04984486 on ClinicalTrials.gov ↗ ← All trials in France