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The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cancellous FDBA (LifeNet) | Experimental | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) |
|
| cortical FDBA (LifeNet) | Experimental | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cortical FDBA | Device | cortical mineralized freeze-dried bone allograft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic Percentage of Vital Bone Formation | Histologic percentage of vital bone formation in bone cores | 18-20 weeks after grafting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian L Mealey, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health Science Center Dental School | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23725026 | Derived | Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cancellous FDBA (LifeNet) | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
| FG001 | Cortical FDBA (LifeNet) | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patietns requring tooth extraction adn ridge preservation
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| ID | Title | Description |
|---|---|---|
| BG000 | Cancellous FDBA (LifeNet) | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
| BG001 | Cortical FDBA (LifeNet) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Histologic Percentage of Vital Bone Formation | Histologic percentage of vital bone formation in bone cores | Posted | Median | Inter-Quartile Range | percentage of vital bone | 18-20 weeks after grafting |
|
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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 | Cancellous FDBA (LifeNet) | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Mealey | UT Health Sci Ctr San Antonio | 210-567-3567 | mealey@uthscsa.edu |
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| Cancellous FDBA |
| Device |
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
|
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Cortical FDBA (LifeNet) | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft | 0 | 20 | 0 | 20 |
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