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

NCT ID: NCT00726063

Last Updated: 2022-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Tooth Disease Partial Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

implant types were randomized- 2 different surface treatments
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nanotite implant

Nanotite dental implant

Group Type EXPERIMENTAL

Nanotite dental implant

Intervention Type DEVICE

Nanotite root form titanium dental implant

Osseotite implant

Osseotite dental implant

Group Type ACTIVE_COMPARATOR

Osseotite dental implant

Intervention Type DEVICE

Osseotite Root form titanium dental implant

Interventions

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Nanotite dental implant

Nanotite root form titanium dental implant

Intervention Type DEVICE

Osseotite dental implant

Osseotite Root form titanium dental implant

Intervention Type DEVICE

Other Intervention Names

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Nanotite endosseous dental implant Osseotite endosseous dental implant

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZimVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S Reddy, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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2613

Identifier Type: -

Identifier Source: org_study_id

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