Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

McGuire Institute

Status: Active, not recruiting

Conditions: Partially Edentulous Maxilla or Mandible

Treatments: Device: PrimeTaper EV

Study type: Interventional

Funder types: Industry

Identifiers

NCT05264545

DS2021-01

Details and patient eligibility

About

A 510k approved dental device for subjects requiring single or multiple tooth replacement with implants where immediate restoration/loading is preferred.

Full description

The rationale for this study is to provide scientific data on the clinical performance and patient reported outcomes of the PrimeTaper EV implant when utilizing non-guided vs guided surgical technique. The PrimeTaper EV implant has the OsseoSpeed surface, which is especially indicated for use in soft bone applications where implants with other surface treatments may be less effective.

The main interests of this study are to assess the survival and the success rates of the implants supporting maxillary or mandibular fixed single or 2-fixture restorations after 1, 2, 3, 4 and 5 years in function

Enrollment: 100 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Single Arm

Other group

Description:

There are no arms in the study, it is a non randomized, controlled study

Treatment:

Device: PrimeTaper EV