Performance of MicroTextured Dental Implants

NCT ID: NCT01821417

Last Updated: 2017-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-10-31

Brief Summary

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The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.

The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.

Detailed Description

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Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.

Conditions

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Partially Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Microtextured dental implant

Randomized for microtextured dental implant treatment

Group Type EXPERIMENTAL

Microtextured dental implant treatment

Intervention Type DEVICE

Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.

Dental implant

Randomized dental implant treatment with machined-collar implants

Group Type ACTIVE_COMPARATOR

Dental implant treatment

Intervention Type DEVICE

Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.

Interventions

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Microtextured dental implant treatment

Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.

Intervention Type DEVICE

Dental implant treatment

Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.

Intervention Type DEVICE

Other Intervention Names

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Screw-vent dental implant

Eligibility Criteria

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Inclusion Criteria

1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient
2. Existence of one or more missing teeth scheduled to be replaced with dental implants
3. Healthy enough to undergo proposed therapy without compromising existing health
4. Able to consent for their own inclusion
5. Able to read and understand the informed consent form
6. Demonstrated willingness to comply with protocol requirements and timeline

Exclusion Criteria

1. Any health condition that in the opinion of the investigators may adversely affect bone healing
2. Any medication that in the opinion of the investigators may adversely affect bone healing
3. Any indication of an inability to make autonomous decisions
4. Reported pregnancy at the time of enrollment -
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zimmer Dental

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael Reddy, DMD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolaas C. Geurs, DDS.MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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Z-11

Identifier Type: -

Identifier Source: org_study_id

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