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When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allograft alone | Active Comparator | guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) |
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| allograft with autograft | Experimental | guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allograft alone | Device | use of MinerOss allograft plus Alloderm GBR membrane and tenting screws |
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| Measure | Description | Time Frame |
|---|---|---|
| Gain in Horizontal Ridge Dimension | 5 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of New Bone Formation (Histologic) | 5 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian L Mealey, DDS, MS | Univ of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of texas Health Science Center Dental School at San Antonio | San Antonio | Texas | 78229-3900 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allograft Alone | guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws |
| FG001 | Allograft Combined With Autograft |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| allograft with autograft | Device | use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws |
|
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Allograft Alone | guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws |
| BG001 | Allograft Combined With Autograft | guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws |
| BG002 | 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 | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Gain in Horizontal Ridge Dimension | Posted | Mean | Standard Deviation | gain in ridge width (mm) | 5 months after surgery |
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| Secondary | Percentage of New Bone Formation (Histologic) | No data were collected for this outcome | Posted | 5 months after surgery |
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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 | Allograft Alone | guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws | 0 | 14 | 0 | 14 | ||
| EG001 | Allograft Combined With Autograft | guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Mealey | UTHSCSA Periodontics | 210-567-3589 | mealey@uthscsa.edu |
| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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