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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.
Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous in the orofacial sphere:
TBR® Tissue Level Z1 implants are intended for placement in the maxillary or mandibular arch in partially or completely edentulous patients for prosthetic restoration in the following cases:
The following clinical conditions must be observed before placing a dental implant:
The procedure used to accomplish its intended use is as follows:
The expected benefits of this surgery are to improve the quality of life of patients, to recover the chewing function and the aesthetics of the smile.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant | Device | 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 with a cover screw to allow the tissues healing. After this healing phase, the final prosthesis will be loaded on the implant. |
| Measure | Description | Time Frame |
|---|---|---|
| the success rate of tissue integration of the implant | Integration of the implant 15 years after implantation | 15 years after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient partially or totally toothless
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet du Dr ALLOUCHE | Montpellier | 34000 | France |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| 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 |
| Measuring chewing function with occlusal assessment | Occlusal assessment will be performed after implantation and at 5 years follow-up | 5 years after implantation |
| 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 |
| 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 |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |