Performance of MicroTextured Dental Implants

Study Overview
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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.

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

Conditions
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Partially Edentulous Jaw

Intervention / Treatment
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* Device: Microtextured dental implant treatment
* Device: Dental implant treatment


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microtextured dental implant<br>Randomized for microtextured dental implant treatment | Device: Microtextured dental implant treatment<br>* 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.<br>* Other names: Screw-vent dental implant;|
| Active Comparator: Dental implant<br>Randomized dental implant treatment with machined-collar implants | Device: Dental implant treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Millimeters of Bone Loss Surrounding the Implant Device | 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 | 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 | Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration. | 1 year after placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, screw-vent dental implants