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Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients | Clinical Trials | Clareo Health

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

Prospective, Multicenter, Non-randomized, Controlled Clinical Study Utilizing Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

NCT05264545•McGuire Institute

View on ClinicalTrials.gov

Summary

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

Detailed 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

Eligibility

Age

25 - No limit years

Sex

ALL

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).
+8 more criteria

Locations (8)

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

Key Dates

Start Date

March 22, 2022

Primary Completion Date

June 1, 2026

Completion Date

October 1, 2026

Last Updated

May 18, 2025

Enrollment

100

ACTUAL participants

Conditions

Partially Edentulous Maxilla or Mandible

Interventions

PrimeTaper EV

DEVICE