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Completed

NCT Number: NCT01821417

Performance of MicroTextured Dental Implants

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.

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Key information

Conditions

Partially Edentulous Jaw Jaw Diseases Jaw, Edentulous Jaw, Edentulous, Partially Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294-0007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any health condition that in the opinion of the investigators may adversely affect bone healing
  • Any medication that in the opinion of the investigators may adversely affect bone healing
  • Any indication of an inability to make autonomous decisions
  • Reported pregnancy at the time of enrollment -

Treatment and study plan

Microtextured dental implant treatment

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.

Other names: Screw-vent dental implant

Dental implant treatment

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Zimmer Dental

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Apr 1, 2013
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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