A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs (CollegeBowl)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00726063
First received: July 29, 2008
Last updated: January 15, 2014
Last verified: January 2014
  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
Tooth Disease
Partial Edentulism
Device: Nanotite dental implant
Device: Osseotite dental implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized-controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs

Resource links provided by NLM:


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 ]

Enrollment: 241
Study Start Date: April 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nanotite implant
Nanotite dental implant
Device: Nanotite dental implant
Nanotite root form titanium dental implant
Other Name: Nanotite endosseous dental implant
Active Comparator: Osseotite implant
Osseotite dental implant
Device: Osseotite dental implant
Osseotite Root form titanium dental implant
Other Name: Osseotite endosseous 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
Birmingham, Alabama, United States, 35294
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, Inc.
ClinicalTrials.gov Identifier: NCT00726063     History of Changes
Other Study ID Numbers: 2613
Study First Received: July 29, 2008
Results First Received: November 19, 2013
Last Updated: January 15, 2014
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

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 16, 2014