An observational study in Edentulous Mouth, sponsored by Sudimplant SAS - Groupe TBR. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Sudimplant SAS - Groupe TBR · 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.
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.
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
This study's enrollment of 152 is above the median of 39 across 52 observational studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →Sudimplant SAS - Groupe TBR is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient partially or totally toothless
Exclusion Criteria:
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.
the success rate of tissue integration of the implant
Integration of the implant 15 years after implantation
Time frame: 15 years after implantation
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
Time frame: 5 years after implantation
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
Time frame: 5 years after implantation
Measuring chewing function with occlusal assessment
Occlusal assessment will be performed after implantation and at 5 years follow-up
Time frame: 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
Time frame: 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
Time frame: 5 years after implantation
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Sudimplant SAS - Groupe TBR