A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Partially Edentulous Jaw
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change in Millimeters of Bone Loss Surrounding the Implant Device
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Michael Reddy, DMD
Professor
University of Alabama at Birmingham
Eligibility Criteria
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 -
Outcomes
Primary Outcomes
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
- Changes in Peri-implant Gingivitis Score(1 year after placement)
- Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device(1 year after placement)