NCT05375045

Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 868 (estimated)
• Sponsor: Euroteknika · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants

Detailed description

Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous at the level of the orofacial sphere : * Edentulism generates a strong aesthetic deficit due to the lack of support of the tissues and the facial musculature; * Edentulism causes a functional deficit that can have significant repercussions on the nutritional status of the affected subject; * Edentulism is accompanied by bone resorption of the jaws which is unavoidable in the absence of implant treatment; * In addition, the resulting feelings of discomfort and fragility are experienced as a real psychological handicap by the patient, partially or totally edentulous, which can then have significant repercussions on his social life. EUROTEKNIKA dental implants are intended to be used for the replacement of a dental root in order to support a fixed or mobile prosthesis and thus restore masticatory function. EUROTEKNIKA dental implants are made of titanium or titanium alloy for surgical implants in accordance with ISO5832-2 and -3 standards. EUROTEKNIKA dental implants are intended for use in cases of single, partial or complete edentulism on the maxillary and/or mandibular arch: * Single tooth loss, * Intercalary toothlessness, * Terminal toothlessness, * Total edentulism. Dental implantology is based on the following principle: an implant is surgically inserted into the maxilla or mandible, and then a pillar is connected to this implant to support the dental prosthesis. The use of dental implants is based on a biological process called osseointegration. Osseointegration corresponding to the fact that certain materials such as titanium are able to form direct contact with the surrounding bone. Osseointegration is therefore the direct structural and functional connection between living bone and the surface of an artificial implant. In order to allow the osseointegration process, and depending on the clinical case, a more or less long healing period must be observed before connecting the prosthetic elements to the implant. In cases of immediate loading, there is no healing period. The expected benefits of this surgery are to improve the quality of life of patients and to recover masticatory function. The claimed clinical performances are: * High primary stability, * High long-term implant stability, * Limitation of bone resorption and risks of mucositis and peri-implantitis * Maintenance of soft tissues. The objectives of this study are therefore to assess the safety and performance of EUROTEKNIKA dental implants.

Conditions

• Edentulous Mouth

Interventions

Type	Name	Description
DEVICE	dental implantation	an implant is surgically inserted into the maxilla or mandible, and then an abutment is connected to this implant to support the dental prosthesis.

Timeline

• Start date: 2022-03-25
• Primary completion: 2027-07-01
• Completion: 2028-02-01
• First posted: 2022-05-16
• Last updated: 2022-05-16

Locations

1 site across 1 country: France