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NCT00726063 Clinical Trial

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

Partial Edentulism Clinical Trial

— CollegeBowl  

Official title:
A Prospective Randomized-controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00726063
Other study ID # 2613
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2008
Est. completion date October 2012

Study information
Verified date March 2022
Source ZimVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Nanotite dental implant
Nanotite root form titanium dental implant
• Osseotite dental implant
Osseotite Root form titanium dental implant

Locations
Country Name City State
United States University of Alabama Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
ZimVie

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Integration Success of the Implant 1 year
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