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

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ClinicalTrials.gov Identifier: NCT00726063
Recruitment Status : Completed
First Posted : July 31, 2008
Results First Posted : February 12, 2014
Last Update Posted : August 30, 2017
Sponsor:
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
Tooth Disease Partial Edentulism Device: Nanotite dental implant Device: Osseotite 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.


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
Primary Completion Date : October 2012
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, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00726063


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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov 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
multicenter
randomized
clinical study
partial edentulism
prosthesis

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases