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

Edentulous Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375045
• Other study ID #: SUIVI IMPLANTS
• Status: Recruiting
• Start date: March 25, 2022
• Est. completion date: February 1, 2028

Study information

• Verified date: May 2022
• Source: Euroteknika
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 868
• Est. completion date: February 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

• Patient to benefit from the placement of an implant for the creation of a single crown (for the prospective cohort)

• Patient implanted with the EUROTEKNIKA dental implant before 2017 (for the retrospective cohort)

• Patient having benefited from the placement of an implant for the creation of a single crown (for the retrospective cohort)

Exclusion Criteria:

• 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)

• Patient to benefit from the placement of an implant with immediate or early loading (for the prospective cohort)

• Patient to benefit from the placement of an implant for the support of the bridge, piles, attachment (for the prospective cohort)

• Patient having benefited from the placement of an implant with immediate or early loading (for the retrospective cohort)

• Patient having benefited from the placement of an implant for the support of the bridge, piles, attachment (for the retrospective cohort)

Related Conditions & MeSH terms

• Edentulous Mouth
• Mouth, Edentulous

Intervention

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.

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Euroteknika	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of tissue integration of the implant	Integration of the implant 5 years after implantation	5 years after implantation
Secondary	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	5 years after implantation
Secondary	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	5 years after implantation
Secondary	measuring chewing function after prosthesis placement	Occlusal assessment will be performed after implantation and at 5 years follow-up	5 years after implantation
Secondary	Rate of inflammation (visual)	Assessment of inflammation with visual examination 5 years after implantation	5 years after implantation
Secondary	Assessment of the evolution of the péri-implant tissues	assessment of the evolution of the péri-implant tissues with the Pink esthetic score	5 years after implantation
Secondary	assessment of the osseointegration of the implant	assessment of the osseointegration of the implant with the ISQ score	5 years after implantation
Secondary	Rate of infection (x-ray)	Assessment of infection with radiographic examination 5 years after implantation	5 years after implantation