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

Last updated: May 14, 2025
Sponsor: McGuire Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

PrimeTaper EV

Clinical Study ID

NCT05264545
DS2021-01
  • Ages > 25
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject ≥25 years.

  2. Subject has signed and dated the informed consent form prior to any studyprocedures.

  3. History of either a healed edentulous area or single or multiple teeth requiringextraction and in need of a single or fixed bridge prosthetic restoration and whereimmediate restoration/loading is preferred.

  4. Opposing jaw in the treatment area meets any of the following stable occlusalconditions:

Complete denture Partial removable denture Fixed bridges and/or crowns Natural dentition

Exclusion

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'sjudgment.

  2. Subject is not willing to participate in the study or not able to understand thecontent 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. untreatedperiodontal 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 healingand/or osseointegration (e.g., uncontrolled diabetes mellitus as reported by thesubject).

  10. Use of systemic corticosteroids, IV bisphosphonates or any other medication thatcould 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 mayinterfere 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 SironaImplants.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: PrimeTaper EV
Phase:
Study Start date:
March 22, 2022
Estimated Completion Date:
October 31, 2026

Study 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

Connect with a study center

  • McClain and Schallhorn Periodontics and Implant Dentistry

    Aurora, Colorado 80012-3260
    United States

    Site Not Available

  • Colorado Gum Care

    Broomfield, Colorado 80020
    United States

    Site Not Available

  • Misch Implant Dentistry

    Sarasota, Florida 34237
    United States

    Site Not Available

  • Periodontal Medicine Surgical Specialists, LLC

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • Metro West Orthodontics & Periodontics

    La Vista, Nebraska 68128
    United States

    Site Not Available

  • Perio & Implant Associates of Middle TN

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Perio Health Professionals

    Houston, Texas 77063-7229
    United States

    Site Not Available

  • Oral Health Specialists

    Tacoma, Washington 98405-1462
    United States

    Site Not Available

  • WisNova Institute of Dental Specialists

    Kenosha, Wisconsin 53144-4292
    United States

    Site Not Available

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