Performance of MicroTextured Dental Implants

Not Applicable

Completed

• Conditions: Partially Edentulous Jaw
• Interventions: Device: Microtextured dental implant treatment; Device: Dental implant treatment

• Registration Number: NCT01821417
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-04-01
• Primary Completion: 2014-06
• Results First Submitted: 2015-07-29
• Study Completion: 2015-10
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Results First Posted: 2017-03-16
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microtextured dental implant	Microtextured dental implant treatment	Randomized for microtextured dental implant treatment
Dental implant	Dental implant treatment	Randomized dental implant treatment with machined-collar implants

Primary Outcome Measures

Name	Time	Method
Change in Millimeters of Bone Loss Surrounding the Implant Device	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

Name	Time	Method
Changes in Peri-implant Gingivitis Score	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	1 year after placement	Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.

Trial Locations

Locations (1)

University of Alabama at Birmingham School of Dentistry; 🇺🇸 Birmingham, Alabama, United States