Phase
Condition
N/ATreatment
PrimeTaper EV
Clinical Study ID
Ages > 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject ≥25 years.
Subject has signed and dated the informed consent form prior to any studyprocedures.
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.
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):
Unlikely to be able to comply with study procedures, according to the Investigator'sjudgment.
Subject is not willing to participate in the study or not able to understand thecontent 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. untreatedperiodontal 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 healingand/or osseointegration (e.g., uncontrolled diabetes mellitus as reported by thesubject).
Use of systemic corticosteroids, IV bisphosphonates or any other medication thatcould 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 mayinterfere 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 SironaImplants.
Study Design
Study Description
Connect with a study center
McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado 80012-3260
United StatesSite Not Available
Colorado Gum Care
Broomfield, Colorado 80020
United StatesSite Not Available
Misch Implant Dentistry
Sarasota, Florida 34237
United StatesSite Not Available
Periodontal Medicine Surgical Specialists, LLC
Oakbrook Terrace, Illinois 60181
United StatesSite Not Available
Metro West Orthodontics & Periodontics
La Vista, Nebraska 68128
United StatesSite Not Available
Perio & Implant Associates of Middle TN
Nashville, Tennessee 37215
United StatesSite Not Available
Perio Health Professionals
Houston, Texas 77063-7229
United StatesSite Not Available
Oral Health Specialists
Tacoma, Washington 98405-1462
United StatesSite Not Available
WisNova Institute of Dental Specialists
Kenosha, Wisconsin 53144-4292
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.