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

Running, not enrolling · Not applicable

Conditions studied: Partially Edentulous Maxilla or Mandible

In brief

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

Key facts

Study ID: NCT05264545
Run by: McGuire Institute
People needed: 100
Starts: 2022-03-22
Expected to finish: 2026-12-01
Last updated by the study team: 2026-06-24

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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):
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.
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).
Use of systemic corticosteroids, IV bisphosphonates or any other medication that could compromise post-operative healing and/or osseointegration.
Current alcohol and/or drug abuse.
Smoking more than 10 cigarettes of any type per day.
Current need for major bone grafting and/or augmentation in the planned implant area (esthetic augmentation and minor facial grafting are allowed).
Known pregnancy, or plans to become pregnant during the study period of 5 years
Participation in another clinical study within the previous 6 months that may interfere with the present study.
Post-surgical Exclusion criteria
Insufficient primary stability, as judged by the investigator, of the implant(s).
Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.

Where it is running

McClain and Schallhorn Periodontics and Implant Dentistry — Aurora, Colorado, United States
Colorado Gum Care — Broomfield, Colorado, United States
Periodontal Medicine Surgical Specialists, LLC — Oakbrook Terrace, Illinois, United States
Metro West Orthodontics & Periodontics — La Vista, Nebraska, United States
Perio & Implant Associates of Middle TN — Nashville, Tennessee, United States
Perio Health Professionals — Houston, Texas, United States
Oral Health Specialists — Tacoma, Washington, United States
WisNova Institute of Dental Specialists — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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