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

NCT05375045 | Recruiting

• 1 other identifier: SUIVI IMPLANTS
• Study Type: observational
• Target: 868
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Edentulous Mouth

Outcome Measures

Primary Outcomes (1)

• The success rate of tissue integration of the implant

  Integration of the implant 5 years after implantation

  5 years after implantation

Secondary Outcomes (7)

• assessment of the quality of life of patients following the recovery of full dentition with the GOHAI score (General Oral Health Assessment Index)

  5 years after implantation

• Complication rate taking into account pain, local tenderness, infection, mobility of the implant, fracture

  5 years after implantation

• measuring chewing function after prosthesis placement

  5 years after implantation

• Rate of inflammation (visual)

  5 years after implantation

• Assessment of the evolution of the péri-implant tissues

  5 years after implantation

Study Arms (2)

prospective

A prospective cohort will be recruited into the study to meet the secondary objective of improving 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.

Device: dental implantation

retrospective

Patients who received one or more EUROTEKNIKA implants before 2017 may be included in the study for the retrospective cohort

Interventions

dental implantation DEVICE

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

prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Euroteknika: lead
• EVAMED: collaborator

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

Dental Implantation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: May 16, 2022
• Study Start: March 25, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)