PrimeTaper EV: The PrimeTaper EV Implant is a screw shaped dental implant with a defined surface achieved through grit blasting, followed by a process involving a treatment in diluted hydrofluoric acid. There is a conical connection between the implants and the abutments for a tight and stable connection.
Study summary
A 510k approved dental device for subjects requiring single or multiple tooth replacement with implants where immediate restoration/loading is preferred.
Eligibility
Sex
ALL
Min age
25 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject ≥25 years.
2. Subject has signed and dated the informed consent form prior to any study procedures.
3. History of either a healed edentulous area or single or multiple teeth requiring extraction and in need of a single or fixed bridge prosthetic restoration and where immediate restoration/loading is preferred.
4. Opposing jaw in the treatment area meets any of the following stable occlusal conditions:
Complete denture Partial removable denture Fixed bridges and/or crowns Natural dentition
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study (all criteria apply at study inclusion, but criteria numbered 1-4 also apply during the entire study period):
1. Unlikely to be able to comply with study procedures, according to the Investigator's judgment.
2. Subject is not willing to participate in the study or not able to understand the content of the study.
3. Involved in the planning and conduct of the study.
4. Unable or unwilling to return for follow-up visits for a period of 5 years.
5. Has an uncontrolled pathological process in the oral cavity (e.g. untreated periodontal disease, uncontrolled caries, severe malocclusion, etc.).
6. Known or suspected current malignancy.
7. History of radiation therapy in the head and neck region.
8. History of chemotherapy within 5 years prior to surgery.
9. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration (e.g., uncontrolled diabetes mellitus as reported by the subject).
10. Use of systemic corticosteroids, IV bisphosphonates or any other medication that could compromise post-operative healing and/or osseointegration.
11. Current alcohol and/or drug abuse.
12. Smoking more than 10 cigarettes of any type per day.
13. Current need for major bone grafting and/or augmentation in the planned implant area (esthetic augmentation and minor facial grafting are allowed).
14. Known pregnancy, or plans to become pregnant during the study period of 5 years
15. Participation in another clinical study within the previous 6 months that may interfere with the present study.
Post-surgical Exclusion criteria
16. Insufficient primary stability, as judged by the investigator, of the implant(s).
17. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
Primary outcome measure(s)
To evaluate implant survival rate at 1 year after final restoration attachment (screw retained when feasible) with single and multiple (fixed bridges) PrimeTaper EV implant(s) utilizing non-guided versus guided surgery — 1 year after final restoration Number of remaining implants counted clinically and radiographically, i.e. 'Yes' or 'No' for each implant where 'Yes' means that the implant is still remaining and 'No' means that the implant is not remaining.
Trial sites (8)
Facility
City
Region
Status
McClain and Schallhorn Periodontics and Implant Dentistry
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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