Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants
ConditionEdentulous Mouth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuroteknika
About this trial
Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 or over
Patient who has completed bone growth
Patient informed and agreeing to participate in the study
Partially or totally edentulous patient who will be implanted with the EUROTEKNIKA dental implant (for the prospective cohort)
Disqualifiers
Pregnant or breastfeeding women (for the prospective cohort)
Patient with bone disease in the cervico-facial region
Patient refusing to participate in the study
Patient with at least one contraindication to implantation (for the prospective cohort)
Trial population
Patients who received one or more EUROTEKNIKA implants before 2017 may be included in the study for the retrospective cohort for Naturactis, Naturall+, Aesthetica+2, ORIGIN, iBone E, iBone S and iBone G implants. These patients will be included consecutively in chronological order to avoid selection bias. A prospective cohort will also be recruited in the study, in order to meet the secondary objective concerning the improvement of the quality of life. In fact, to measure the improvement in quality of life, a questionnaire must be completed by the patient before the implant is placed. Answers to this questionnaire preoperatively cannot be collected for patients recruited retrospectively.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
dental implantation
Devicean implant is surgically inserted into the maxilla or mandible, and then an abutment is connected to this implant to support the dental prosthesis.
Treatment groups
868 Participants
are divided into 2 treatment groupsGroup A: prospective1 intervention
Group B: retrospective0 interventions
Trial outcomes
Primary outcomes
1
The success rate of tissue integration of the implant
Integration of the implant 5 years after implantation
Time frame
5 years after implantationSecondary outcomes
1
assessment of the quality of life of patients following the recovery of full dentition with the GOHAI score (General Oral Health Assessment Index)
the quality of life of patients will be evaluated with the GOHAI score before implantation and 5 years after implantation
Time frame
5 years after implantation2
Complication rate taking into account pain, local tenderness, infection, mobility of the implant, fracture
pain, local tenderness, infection, mobility of the implant, fracture will be collected during the 5 years follow-up
Time frame
5 years after implantation3
measuring chewing function after prosthesis placement
Occlusal assessment will be performed after implantation and at 5 years follow-up
Time frame
5 years after implantation4
Rate of inflammation (visual)
Assessment of inflammation with visual examination 5 years after implantation
Time frame
5 years after implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Euroteknika
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov