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The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
The study is designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The study is a 3-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination 50% cortical/50% cancellous FDBA | Experimental | Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) |
|
| 100% cortical FDBA | Active Comparator | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) |
|
| 100% cancellous FDBA | Active Comparator | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50% cortical/50% cancellous FDBA | Device | Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Vital Bone Formation (Histological) | histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery | 18-20 weeks after ridge preservation |
| Measure | Description | Time Frame |
|---|---|---|
| % Residual Graft Material (Histological) | histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery | 18-20 weeks after ridge preservation |
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Inclusion Criteria: Patients will be included in this study if they qualify the following inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian L Mealey, DDS, MS | UT Health Science Center at San Antonio, School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health Science Center at San Antonio, School of Dentistry | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28452622 | Derived | Demetter RS, Calahan BG, Mealey BL. Histologic Evaluation of Wound Healing After Ridge Preservation With Cortical, Cancellous, and Combined Cortico-Cancellous Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Sep;88(9):860-868. doi: 10.1902/jop.2017.170155. Epub 2017 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination 50% Cortical/50% Cancellous FDBA | Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA |
| FG001 | 100% Cortical FDBA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 100% cortical FDBA | Device | Ridge preservation after tooth extraction using 100% cortical FDBA |
|
| 100% cancellous FDBA | Device | Ridge preservation after tooth extraction using 100% cancellous FDBA |
|
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA |
| FG002 | 100% Cancellous FDBA | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination 50% Cortical/50% Cancellous FDBA | Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA |
| BG001 | 100% Cortical FDBA | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA |
| BG002 | 100% Cancellous FDBA | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | % Vital Bone Formation (Histological) | histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery | Posted | Mean | Standard Deviation | percentage of total area | 18-20 weeks after ridge preservation |
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| Secondary | % Residual Graft Material (Histological) | histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery | Posted | Mean | Standard Deviation | percentage of total area | 18-20 weeks after ridge preservation |
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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 | Combination 50% Cortical/50% Cancellous FDBA | Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA | 0 | 22 | 0 | 22 | ||
| EG001 | 100% Cortical FDBA | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA | 0 | 22 | 0 | 22 | ||
| EG002 | 100% Cancellous FDBA | Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian L. Mealey DDS, MS | Univ of Texas Health Sci Ctr San Antonjio, Dept of Periodontics | 210-567-3567 | mealey@uthscsa.edu |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Male |
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| Participants |
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