Edentulous Mouth Clinical Trial
— Z1Official title:
In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1 With Ceramic Emergence
Verified date | April 2024 |
Source | Sudimplant SAS - Groupe TBR |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 152 |
Est. completion date | July 2027 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Cabinet du Dr ALLOUCHE | Montpellier |
Lead Sponsor | Collaborator |
---|---|
Sudimplant SAS - Groupe TBR |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the success rate of tissue integration of the implant | Integration of the implant 15 years after implantation | 15 years after implantation | |
Secondary | Change of the quality of life of patients following the recovery of a complete dentition with the OHIP- 14 score (Oral Health Impact Profile) | The quality of life of patients will be evaluate with the OHIP- 14 score (Oral Health Impact Profile) before implantation and 5 years after implantation | 5 years after implantation | |
Secondary | Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture | pain, local tenderness, infection, allergy, mobility of the implant, fracture will be collected during during the 5 years follow-up | 5 years after implantation | |
Secondary | Measuring chewing function with occlusal assessment | Occlusal assessment will be performed after implantation and at 5 years follow-up | 5 years after implantation | |
Secondary | Radiographic analysis of the osseointegration of the implant | A radiographic analysiswill be performed after implantation and at 5 years follow-up to evaluate the osseointegration of the implant | 5 years after implantation | |
Secondary | Absence of inflammation (visual) and infection (radiographic) | Assessment of inflammation with visual examination and assessment of infection with radiographic examination 5 years after implantation | 5 years after implantation |
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