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A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New alloplastic bone graft material | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easy-graft (beta-Tricalcium Phosphate) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Radiographic Measurement of Alveolar Ridge Height | Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration). | Change from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Alloplastic Bone Graft Material | easy-graft (beta-Tricalcium Phosphate) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Alloplastic Bone Graft Material | easy-graft (beta-Tricalcium Phosphate) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage Change in Radiographic Measurement of Alveolar Ridge Height | Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration). | Posted | Mean | Standard Deviation | percentage of change | Change from baseline to 6 months |
|
|
6 months
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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 | New Alloplastic Bone Graft Material | easy-graft (beta-Tricalcium Phosphate) | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akane Takemura, R&D Senior Manager | Sunstar Americas, Inc. | 847-794-4276 | akane.takemura@us.sunstar.com |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Widest ridge width | Mean | Standard Deviation | mm |
|
| Deepest vertical depth | Mean | Standard Deviation | mm |
|
| Widest open | Mean | Standard Deviation | mm |
|
|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 30 days from the time submitted to the sponsor for review. Sponsor reserves the right to require the PI to remove sponsor's confidential information. Upon sponsor's written request, publication will be delayed up to 60 days to enable sponsor to secure adequate intellectual property protection.