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The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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 cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). 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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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 |
|---|---|---|---|
| PUROS (Non-Freeze-Dried bone allograft) | Experimental | Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS) |
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| FDBA (Freeze-Dried bone allograft) | Active Comparator | Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUROS (Ridge Preservation bone grafting surgery) | Device | Ridge preservation bone grafting after tooth extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Vital Bone Formation (Histological) | histologic determination of % of vital bone formation | 3 months after ridge preservation |
| Measure | Description | Time Frame |
|---|---|---|
| % Residual Graft Material (Histological) | histologic determination of % of residual bone graft material | 3 months 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 |
|---|---|---|---|
| 30161278 | Derived | Corning PJ, Mealey BL. Ridge preservation following tooth extraction using mineralized freeze-dried bone allograft compared to mineralized solvent-dehydrated bone allograft: A randomized controlled clinical trial. J Periodontol. 2019 Feb;90(2):126-133. doi: 10.1002/JPER.18-0199. Epub 2018 Sep 19. |
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After enrollment, one subject was withdrawn as a screen failure. This left a total of 43 subjects enrolled to take part in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Freeze-Dried Bone Allograft (PUROS) | Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS) PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction |
| FG001 | Freeze-Dried Bone Allograft (FDBA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2015 |
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| FDBA (Ridge Preservation bone grafting surgery) | Device | Ridge preservation bone grafting after tooth extraction |
|
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA) FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Freeze-Dried Bone Allograft (PUROS) | Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS) PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction |
| BG001 | Freeze-Dried Bone Allograft (FDBA) | Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA) FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 % of vital bone formation | Posted | Mean | Standard Deviation | percentage | 3 months after ridge preservation |
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| Secondary | % Residual Graft Material (Histological) | histologic determination of % of residual bone graft material | Posted | Mean | Standard Deviation | percentage | 3 months after ridge preservation |
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20 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 | Non-Freeze-Dried Bone Allograft (PUROS) | Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS) PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction | 0 | 21 | 1 | 21 | 0 | 21 |
| EG001 | Freeze-Dried Bone Allograft (FDBA) | Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA) FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction | 0 | 22 | 0 | 22 | 0 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head trauma | Injury, poisoning and procedural complications | Non-systematic Assessment | Patient fell at home, head trauma, went into ER, hospitalized for 2 days, MRI, CT scan, obtained medical clearance, follow up in with MD |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Mealey | UT Health Science Center at San Antonio | 210-567-3567 | mealey@uthscsa.edu |
| Oct 25, 2017 |
| Prot_SAP_000.pdf |
| 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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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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