Active — Not RecruitingNot Applicable

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

United States100 participantsStarted 2022-03-22

Plain-language summary

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

Who can participate

Age range25 Years

SexALL

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Inclusion criteria

✓. Subject ≥25 years.
✓. Subject has signed and dated the informed consent form prior to any study procedures.
✓. 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.
✓. Opposing jaw in the treatment area meets any of the following stable occlusal conditions:

Exclusion criteria

✕. Unlikely to be able to comply with study procedures, according to the Investigator's judgment.
✕. Subject is not willing to participate in the study or not able to understand the content of the study.
✕. Involved in the planning and conduct of the study.
✕. Unable or unwilling to return for follow-up visits for a period of 5 years.
✕. Has an uncontrolled pathological process in the oral cavity (e.g. untreated periodontal disease, uncontrolled caries, severe malocclusion, etc.).
✕. Known or suspected current malignancy.
✕. History of radiation therapy in the head and neck region.
✕. History of chemotherapy within 5 years prior to surgery.

What they're measuring

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

Timeframe: 1 year after final restoration

Trial details

NCT IDNCT05264545

SponsorMcGuire Institute

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Partially Edentulous Maxilla or Mandible trials