A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Edentulism
Intervention: Dental implant Nanotite (Device); Dental implant Osseotite (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet 3i, LLC Official(s) and/or principal investigator(s):
Michael S Reddy, DMD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Summary
This study will evaluate the contributions of the Nanotite implant design when used by
graduate students in their first year of placing implants.
Clinical Details
Official title: A Prospective Randomized-Controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs
Study design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: integration success of the implant
Secondary outcome: Prosthesis survival and procedural success
Detailed description:
This multicenter, prospective, randomized-controlled study will compare the performance of
the Nanotite vs. the standard Ossotite implants when placed by graduate students with little
or no prior experience. Enrolled patients will have the study site(s) randomized to either a
Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the
participating center will be followed for this study.
Study Hypothesis: The performance of the Nanotite implant in this study will be no different
than or superior to that of the Osseotite implant placed during the early period of graduate
student training.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients of either sex and of any race, 18 years of age or older
- patients for whom a decision has already been made to use dental implants for treating
edentulism in the mandible or maxilla
Exclusion Criteria:
- patients who are known to be pregnant
Locations and Contacts
University of Alabama Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Michael S Reddy, DMD, Phone: 205-934-4984, Email: mreddy@uab.edu
Additional Information
Starting date: December 2007
Ending date: January 2012
Last updated: July 30, 2008
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