Status:
ACTIVE_NOT_RECRUITING
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Lead Sponsor:
McGuire Institute
Collaborating Sponsors:
Dentsply Sirona Implants and Consumables
Conditions:
Partially Edentulous Maxilla or Mandible
Eligibility:
All Genders
25+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05264545
Start Date
March 22 2022
End Date
October 1 2026
Last Update
May 18 2025
Active Locations (8)
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1
McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado, United States, 80012-3260
2
Colorado Gum Care
Broomfield, Colorado, United States, 80020
3
Periodontal Medicine Surgical Specialists, LLC
Oakbrook Terrace, Illinois, United States, 60181
4
Metro West Orthodontics & Periodontics
La Vista, Nebraska, United States, 68128