Performance of MicroTextured Dental Implants
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|ClinicalTrials.gov Identifier: NCT01821417|
Recruitment Status : Completed
First Posted : April 1, 2013
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
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 or disease||Intervention/treatment||Phase|
|Partially Edentulous Jaw||Device: Microtextured dental implant treatment Device: Dental implant treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||October 2015|
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.
- 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.
- 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.
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
|United States, Alabama|
|University of Alabama at Birmingham School of Dentistry|
|Birmingham, Alabama, United States, 35294-0007|
|Principal Investigator:||Nicolaas C. Geurs, DDS.MS||University of Alabama at Birmingham|