Active — Not RecruitingNot Applicable

In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1

France152 participantsStarted 2021-09-23

Plain-language summary

Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically. TBR® Tissue Level Z1 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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® TISSUE LEVEL Z1 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.

What they're measuring

the success rate of tissue integration of the implant

Timeframe: 15 years after implantation

Trial details

NCT IDNCT04984499

SponsorSudimplant SAS - Groupe TBR

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-07