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The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.
Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrasocket graft | Active Comparator | Positive control |
|
| Intrasocket plus facial overlay graft | Experimental | Intrasocket cancellous allograft plus a facial overlay bovine xenograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrasocket graft | Procedure | Intrasocket mineralized cancellous allograft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal Ridge Dimension | WIll be measured with a digital caliper at baseline and 4 months. | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic Healing of the Osseous Graft | Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Greenwell, DMD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graduate Periodontics Clinic, School of Dentistry, University of Louisville | Louisville | Kentucky | 40202 | United States |
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The study was conducted between September 2011 and July 2012 in the Graduate Periodontics clinic at the University of Louisville School of Dentistry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrasocket Graft | Positive control, an intrasocket cancellous allograft is placed |
| FG001 | Intrasocket Plus Facial Overlay Graft | Intrasocket cancellous allograft plus a facial overlay bovine xenograft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrasocket Graft | Positive control, an intrasocket cancellous allograft was placed |
| BG001 | Intrasocket Plus Facial Overlay Graft | Intrasocket cancellous allograft plus a facial overlay bovine xenograft |
| 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 | Horizontal Ridge Dimension | WIll be measured with a digital caliper at baseline and 4 months. | Posted | Mean | Standard Deviation | mm | Baseline and 4 months |
|
|
From the beginning to the end of the study.
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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 | Intrasocket Graft | Positive control, an intrasocket cancellous allograft will be placed |
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There were no adverse events.
1 patient in the Intrasocket plus facial overlay graft group was excluded as an outlier. There was a large amount of bone gain and this skewed the data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry Greenwell, Principal Investigator | University of Louisville | 502-852-6928 | henry.greenwell@louisville.edu |
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| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Intrasocket plus facial overlay graft |
| Procedure |
Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Histologic Healing of the Osseous Graft | Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages | Posted | Mean | Standard Deviation | percentage vital bone | 4 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Intrasocket Plus Facial Overlay Graft | Intrasocket cancellous allograft plus a facial overlay bovine xenograft | 0 | 12 | 0 | 12 |
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