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The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This 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 porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. 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 bovine xenograft and porcine xenograft materials.
This entire protocol involves procedures that are standard care. The study is a 2-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
In keeping with the protocol our study group has used several times before, the plan will be to extract non-molar teeth and graft with the test/control materials. Each subject will provide a single non-molar tooth site for study treatment. The graft material will be covered with a non-resorbable dense polytetrafluoroethylene (d-PTFE) membrane (TXT-200 singles, Osteogenics Inc). This d-PTFE membrane will be removed 4 weeks after placement during the 4-week post-op visit. Following 18-20 weeks of healing, the dental implant will be placed. To place a dental implant, an osteotomy (hole in the bone) is prepared into which the implant is placed. This osteotomy can be prepared with either a solid drill, in which case the bone that is removed is suctioned into the suction system, or with a hollow trephine drill into which a core of bone can be collected. The only "research procedure" being done in the current study is the collection of this bone core biopsy for histologic evaluation. 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 |
|---|---|---|---|
| Test: Porcine Xenograft (Zcore) | Experimental | Ridge preservation bone grafting surgery with porcine xenograft (Zcore) |
|
| Active Control: Bovine Xenograft (Bio-Oss) | Active Comparator | Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porcine Xenograft (Zcore) | Device | Ridge preservation bone grafting after tooth extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Vital Bone Formation (Histological) | histologic determination of % vital bone formation | 18-20 weeks after ridge preservation |
| Measure | Description | Time Frame |
|---|---|---|
| % Residual Graft Material (Histological) | histologic determination of % residual bone graft material | 18-20 weeks after ridge preservation |
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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 School of Dentistry | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31380563 | Derived | Lai VJ, Michalek JE, Liu Q, Mealey BL. Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial. J Periodontol. 2020 Mar;91(3):361-368. doi: 10.1002/JPER.19-0211. Epub 2019 Aug 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test: Porcine Xenograft (Zcore) | Ridge preservation bone grafting surgery with porcine xenograft (Zcore) Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction |
| FG001 | Active Control: Bovine Xenograft (Bio-Oss) | Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss) Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test: Porcine Xenograft (Zcore) | Ridge preservation bone grafting surgery with porcine xenograft (Zcore) Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction |
| BG001 | Active Control: Bovine Xenograft (Bio-Oss) |
| 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 | % Vital Bone Formation (Histological) | histologic determination of % vital bone formation | Posted | Mean | Standard Deviation | % vital bone | 18-20 weeks after ridge preservation |
|
18 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 | Test: Porcine Xenograft (Zcore) | Ridge preservation bone grafting surgery with porcine xenograft (Zcore) Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Skin and subcutaneous tissue disorders | serious | Non-systematic Assessment | Patient developed squamous cell carcinoma *not related to study) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fractured arm | Musculoskeletal and connective tissue disorders | serious | Non-systematic Assessment | patient had an accident and broke her arm (unrelated to study) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Mealey | UT Health Science Center at San Antonio | 210-567-3567 | mealey@uthscsa.edu |
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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 8, 2016 | Jan 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| Bovine Xenograft (Bio-Oss) | Device | Ridge preservation bone grafting after tooth extraction |
|
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss) Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | % Residual Graft Material (Histological) | histologic determination of % residual bone graft material | Posted | Mean | Standard Deviation | % residual graft material | 18-20 weeks after ridge preservation |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 1 |
| 22 |
| EG001 | Active Control: Bovine Xenograft (Bio-Oss) | Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss) Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction | 0 | 22 | 1 | 22 | 0 | 22 |
|
|
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| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |