NCT01573026

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

5.6 years

First QC Date

April 4, 2012

Last Update Submit

April 5, 2012

Conditions

Dental Implants

Keywords

Dental ImplantsDental ImplantationOsseointegration

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Newport Coast Oral Facial Institute

Newport Beach, California, 92660, United States

Location

Brighton Periodontal & Implant Dental Group

Woodland Hills, California, 91367, United States

Location

Periodontal Medicine & Surgical Specialists, LTD

Oakbrook Terrace, Illinois, 60181, United States

Location

Kevin G. Murphy & Associates, PA

Baltimore, Maryland, 21209, United States

Location

Specialized Dentistry of New York

New York, New York, 10155, United States

Location

Edwin Rosenberg, DMD, HDD, BDS

Philadelphia, Pennsylvania, 19102, United States

Location

PerioHealth Professionals, PLLC

Houston, Texas, 77042, United States

Location

Dental Design

Gainesville, Virginia, 20155, United States

Location

Study Officials

  • Dennis Tarnow, DDS

    Specialized Dentistry of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 6, 2012

Study Start

August 1, 2011

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

US(8)