A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs - Full Text View

Sponsor:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00726063

Purpose

This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.

Condition	Intervention
Edentulism	Device: Dental implant Nanotite Device: Dental implant Osseotite

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective Randomized-controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

integration success of the implant [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Prosthesis survival and procedural success [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test implant: Active Comparator Nanotite implant	Device: Dental implant Nanotite root form titanium dental implant
Control implant: Placebo Comparator osseotite implant	Device: Dental implant Osseotite Root form titanium dental implant

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726063

Locations

United States, Alabama
University of Alabama Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Michael S Reddy, DMD 205-934-4984 mreddy@uab.edu

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Michael S Reddy, DMD

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	Biomet 3i, Inc. ( Jim Kenealy, Pharm.D,; Director Clinical Research )
Study ID Numbers:	2613
Study First Received:	July 29, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00726063 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

dental implants
Nanotite implant
Osseotite implants
multicenter

randomized
clinical study
partial edentulism
prosthesis

ClinicalTrials.gov processed this record on February 08, 2010