An interventional study of Microtextured dental implant treatment and Dental implant treatment in Partially Edentulous Jaw, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-16.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
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.
171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.
This study's enrollment of 68 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomized for microtextured dental implant treatment
Device: Microtextured dental implant treatment
Randomized dental implant treatment with machined-collar implants
Device: 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.
Also known as: Screw-vent dental implant
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
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Time frame: Implant insertion, 12 months post-insertion
Changes in Peri-implant Gingivitis Score
Measurement of changes in peri-implant gingivitis score \[Loe and Silness gingival index (GI)\] after implant restoration
Time frame: 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.
Time frame: 1 year after placement
| Milestone | Microtextured Dental Implant | Dental Implant |
|---|---|---|
| Started | 37 | 31 |
| Completed | 37 | 31 |
| Not completed | 0 | 0 |
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
| millimeters | Microtextured Dental Implant | Dental Implant |
|---|---|---|
| Change in Millimeters of Bone Loss Surrounding the Implant Device | -0.35 ± 0.56 | -0.82 ± 0.70 |
Measurement of changes in peri-implant gingivitis score \[Loe and Silness gingival index (GI)\] after implant restoration
No measurements were reported for this outcome.
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.
No measurements were reported for this outcome.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Microtextured Dental Implant | — | 0/37 (0%) | 0/37 (0%) |
| Dental Implant | — | 0/31 (0%) | 0/31 (0%) |
| Age, Customized(participants) | Microtextured Dental Implant | Dental Implant | Total |
|---|---|---|---|
| Greater than 19 years | 37 | 31 | 68 |
| Sex: Female, Male(Participants) | Microtextured Dental Implant | Dental Implant | Total |
|---|---|---|---|
| Female | 16 | 11 | 27 |
| Male | 21 | 20 | 41 |
| Ethnicity (NIH/OMB)(Participants) | Microtextured Dental Implant | Dental Implant | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 35 | 31 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Microtextured Dental Implant | Dental Implant | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 8 | 15 |
| White | 28 | 23 | 51 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Microtextured Dental Implant | Dental Implant | Total |
|---|---|---|---|
| United States | 37 | 31 | 68 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham