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Performance of MicroTextured Dental Implants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01821417
First Posted: April 1, 2013
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Dental
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham
  Purpose

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.


Condition Intervention
Partially Edentulous Jaw Device: Microtextured dental implant treatment Device: Dental implant treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar

Further study details as provided by Michael Reddy, DMD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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.


Enrollment: 68
Study Start Date: May 2011
Study Completion Date: October 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821417


Locations
United States, Alabama
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
University of Alabama at Birmingham
Zimmer Dental
Investigators
Principal Investigator: Nicolaas C. Geurs, DDS.MS University of Alabama at Birmingham
  More Information

Responsible Party: Michael Reddy, DMD, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01821417     History of Changes
Other Study ID Numbers: Z-11
First Submitted: March 13, 2013
First Posted: April 1, 2013
Results First Submitted: July 29, 2015
Results First Posted: March 16, 2017
Last Update Posted: March 16, 2017
Last Verified: January 2017

Keywords provided by Michael Reddy, DMD, University of Alabama at Birmingham:
dental implants
screw-vent dental implants

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases