Performance of MicroTextured Dental Implants

January 26, 2017 updated by: Michael Reddy, DMD, University of Alabama at Birmingham

A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama at Birmingham School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microtextured dental implant
Randomized for microtextured dental implant treatment
Device: 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.
Other Names:
  • Screw-vent dental implant
Active Comparator: Dental implant
Randomized dental implant treatment with machined-collar implants
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Millimeters of Bone Loss Surrounding the Implant Device
Time Frame: Implant insertion, 12 months post-insertion
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Implant insertion, 12 months post-insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Peri-implant Gingivitis Score
Time Frame: 1 year after placement
Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration
1 year after placement
Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
Time Frame: 1 year after placement
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.
1 year after placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Zimmer Dental

Investigators

  • Principal Investigator: Nicolaas C. Geurs, DDS.MS, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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