Five Year Survival Study Evaluating the Genesis Dental Implant System

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aptiv Solutions
Pirkka Nummikoski, DDS, MS
CadBlu North (Hastings, MN)
Information provided by (Responsible Party):
Keystone Dental, Inc.
ClinicalTrials.gov Identifier:
NCT01573026
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition
Dental Implants

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Analysis of a Biomimetic Implant System: Five Year Survival Rates, Marginal Bone-level Changes, and Soft Tissue Aesthetics.

Further study details as provided by Keystone Dental, Inc.:

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects between the ages of 18 and 85 who require dental implants

Criteria

Inclusion Criteria:

  • Subject must be between 18 and 85 years old, inclusive, and have passed growth maximum at the time of implant placement
  • Subject must be willing to sign the informed consent document and adhere to study procedures.
  • Subject must have one or more natural teeth missing or about to be extracted.
  • Subject must fulfill all the accepted medical and dental requirements for treatment with dental implants.
  • Subject must desire treatment with dental implants.

Exclusion Criteria:

  • Subject refuses to sign the informed consent document.
  • Subject's treatment success by both clinical and esthetic measures may be compromised by the restricted range of product available for the study.
  • The treatment plan to use the range of products available is not in the best interests of the subject. Please see Section 1.2.1 for restrictions on product availability.
  • The implant site(s) had a previously failed implant.
  • Subject cannot be treated within the restrictions of the treatment plan laid out in Section 5. In addition, please see Section 1.2.1 for restrictions on product availability.
  • Subject with alveolar ridge dimensions that are not sufficient to accommodate and sustain proper implant placement.
  • Subject is not communicable in an understandable language.
  • Current Alcohol or Drug Abuse (within previous 12 months) as noted in the subject's chart.
  • Women who are pregnant at time of enrollment in to the study.
  • Subject with out of control metabolic disease.
  • Subject who have been on chemotherapy or long term cortisone use (at any time).
  • Subject with known allergy to titanium.
  • Subject with diabetes.
  • Subject with a history of autoimmune disease (e.g. documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g. human immunodeficiency virus or acquired immunodeficiency syndrome).
  • Subject with epilepsy.
  • Subjects with uncontrolled or severe cases of hyperthyroidism, malignancies, renal disease, liver problems, hypertension, leukemia, severe vascular heart disease, hepatitis, collagen and bone diseases, or other serious illnesses.
  • Subject currently taking bisphosphonate or calcium channel blockers.
  • There is reasonable doubt that the subject will comply with the recall schedule.
  • There is reasonable doubt that the subject will comply with the clinicians' instructions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573026

Locations
United States, California
Newport Coast Oral Facial Institute
Newport Beach, California, United States, 92660
Brighton Periodontal & Implant Dental Group
Woodland Hills, California, United States, 91367
United States, Illinois
Periodontal Medicine & Surgical Specialists, LTD
Oakbrook Terrace, Illinois, United States, 60181
United States, Maryland
Kevin G. Murphy & Associates, PA
Baltimore, Maryland, United States, 21209
United States, New York
Specialized Dentistry of New York
New York, New York, United States, 10155
United States, Pennsylvania
Edwin Rosenberg, DMD, HDD, BDS
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
PerioHealth Professionals, PLLC
Houston, Texas, United States, 77042
United States, Virginia
Dental Design
Gainesville, Virginia, United States, 20155
Sponsors and Collaborators
Keystone Dental, Inc.
Aptiv Solutions
Pirkka Nummikoski, DDS, MS
CadBlu North (Hastings, MN)
Investigators
Principal Investigator: Dennis Tarnow, DDS Specialized Dentistry of New York
  More Information

No publications provided

Responsible Party: Keystone Dental, Inc.
ClinicalTrials.gov Identifier: NCT01573026     History of Changes
Other Study ID Numbers: KD-CR 02
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Keystone Dental, Inc.:
Dental Implants
Dental Implantation
Osseointegration

ClinicalTrials.gov processed this record on September 16, 2014