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| Name | Class |
|---|---|
| Zimmer Dental | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microtextured dental implant | Experimental | Randomized for microtextured dental implant treatment |
|
| Dental implant | Active Comparator | Randomized dental implant treatment with machined-collar implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microtextured dental implant treatment | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolaas C. Geurs, DDS.MS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Dentistry | Birmingham | Alabama | 35294-0007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microtextured Dental Implant | Randomized for microtextured dental implant treatment 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. |
| FG001 | Dental Implant | Randomized dental implant treatment with machined-collar implants 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Microtextured Dental Implant | Randomized for microtextured dental implant treatment 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | millimeters | Implant insertion, 12 months post-insertion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microtextured Dental Implant | Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures. Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolaas C. Geurs, DDS MS | University of Alabama at Birmingham | 2059344506 | ngeurs@uab.edu |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Dental implant treatment | Device | 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. |
|
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration. |
| 1 year after placement |
| Dental Implant |
Randomized dental implant treatment with machined-collar implants 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. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Changes in Peri-implant Gingivitis Score | Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration | No data was collected. Previously entered data was entered incorrectly. | Posted | 1 year after placement |
|
|
| Secondary | 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. | No data was collected. Previously entered data was entered incorrectly. | Posted | 1 year after placement |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Dental Implant | Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures. Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures. | 0 | 31 | 0 | 31 |
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |