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

Primary Purpose

Tooth Disease, Partial Edentulism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nanotite dental implant

Osseotite dental implant

About this trial

This is an interventional treatment trial for Tooth Disease focused on measuring dental implants, Nanotite implant, Osseotite implants, multicenter, randomized, clinical study, partial edentulism, prosthesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nanotite implant

Osseotite implant

Arm Description

Nanotite dental implant

Osseotite dental implant

Outcomes

Primary Outcome Measures

Integration Success of the Implant

Secondary Outcome Measures

Full Information

NCT ID

NCT00726063

First Posted

July 29, 2008

Last Updated

March 24, 2022

Sponsor

ZimVie

1. Study Identification

Unique Protocol Identification Number

NCT00726063

Brief Title

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

Acronym

CollegeBowl

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

April 2008 (Actual)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZimVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Disease, Partial Edentulism

Keywords

dental implants, Nanotite implant, Osseotite implants, multicenter, randomized, clinical study, partial edentulism, prosthesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

implant types were randomized- 2 different surface treatments

Masking

None (Open Label)

Allocation

Randomized

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nanotite implant

Arm Type

Experimental

Arm Description

Nanotite dental implant

Arm Title

Osseotite implant

Arm Type

Active Comparator

Arm Description

Osseotite dental implant

Intervention Type

Device

Intervention Name(s)

Nanotite dental implant

Other Intervention Name(s)

Nanotite endosseous dental implant

Intervention Description

Nanotite root form titanium dental implant

Intervention Type

Device

Intervention Name(s)

Osseotite dental implant

Other Intervention Name(s)

Osseotite endosseous dental implant

Intervention Description

Osseotite Root form titanium dental implant

Primary Outcome Measure Information:

Title

Integration Success of the Implant

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael S Reddy, DMD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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