The purpose of this research study is to document the use if the Keystone Dental Genesis Dental Implant System in standard clinical use and to provide 5 year survival data.
The technology behind dental implants is well established and the Genesis Dental Implant System has been cleared for marketing by the FDA. It is Keystone Dental's choice to collect post-market data within the framework of a clinical trial in order to assess the clinical performance of this device. The risks of the Genesis Dental Implant System are no different than other comparable dental implant systems currently in use. Keystone Dental expects the clinical performance of this device to be equal to that of comparable implant systems. The purpose of this research study is to assess the 5 year survival rate of the Genesis Dental Implant System, as well as assess the safety and effectiveness endpoints, which include incidence of adverse effects, change in bone height and soft tissue aesthetic outcomes.
Study Type
OBSERVATIONAL
Enrollment
120
Newport Coast Oral Facial Institute
Newport Beach, California, United States
Brighton Periodontal & Implant Dental Group
Woodland Hills, California, United States
Periodontal Medicine & Surgical Specialists, LTD
Oakbrook Terrace, Illinois, United States
Kevin G. Murphy & Associates, PA
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Baltimore, Maryland, United States
Specialized Dentistry of New York
New York, New York, United States
Edwin Rosenberg, DMD, HDD, BDS
Philadelphia, Pennsylvania, United States
PerioHealth Professionals, PLLC
Houston, Texas, United States
Dental Design
Gainesville, Virginia, United States