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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726063
Recruitment Status : Completed
First Posted : July 31, 2008
Results First Posted : February 12, 2014
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment Phase
Tooth Disease Partial Edentulism Device: Nanotite dental implant Device: Osseotite dental implant Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: implant types were randomized- 2 different surface treatments
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized-controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs
Study Start Date : April 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Integration Success of the Implant [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Prosthesis Survival and Procedural Success [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00726063

United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Zimmer Biomet
Principal Investigator: Michael S Reddy, DMD University of Alabama at Birmingham

Responsible Party: Zimmer Biomet Identifier: NCT00726063     History of Changes
Other Study ID Numbers: 2613
First Posted: July 31, 2008    Key Record Dates
Results First Posted: February 12, 2014
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
dental implants
Nanotite implant
Osseotite implants
clinical study
partial edentulism

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases