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

Not Applicable

Completed

• Conditions: Tooth Disease; Partial Edentulism
• Interventions: Device: Osseotite dental implant; Device: Nanotite dental implant

• Registration Number: NCT00726063
• Lead Sponsor: ZimVie

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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-07-31
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-11-19
• Results First Submitted QC: 2014-01-15
• Results First Posted: 2014-02-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osseotite implant	Osseotite dental implant	Osseotite dental implant
Nanotite implant	Nanotite dental implant	Nanotite dental implant

Primary Outcome Measures

Name	Time	Method
Integration Success of the Implant	1 year

Trial Locations

Locations (1)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States