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This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched.
Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement.
The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Oss® Collagen, | Active Comparator | subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.) |
|
| Ossix™ Bone | Experimental | subjects treated with Ossix™ Bone (Datum Dental Ltd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ossix™ Bone | Device | a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Vital Bone Formation, | shows the amount of new bone formed after the procedure | 16 weeks |
| Percent Residual Graft Material | shows how much of the graft material remained intact | 16 weeks |
| Percent Fibrous Tissue and Marrow Space | amount of tissue that is neither native bone or graft material | 16 weeks |
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Inclusion Criteria:
One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
Exclusion Criteria:
Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio (UTHSA) | San Antonio | Texas | 78229-3900 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35661358 | Derived | Casarez-Quintana A, Mealey BL, Kotsakis G, Palaiologou A. Comparing the histological assessment following ridge preservation using a composite bovine-derived xenograft versus an alloplast hydroxyapatite-sugar cross-linked collagen matrix. J Periodontol. 2022 Nov;93(11):1691-1700. doi: 10.1002/JPER.22-0149. Epub 2022 Jul 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bio-Oss® Collagen, | subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.) Bio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen |
| FG001 | Ossix™ Bone | subjects treated with Ossix™ Bone (Datum Dental Ltd) Ossix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BioOss Collagen | no adverse events were observed |
| BG001 | Ossix™ Bone | no adverse events were observed |
| 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 | Percent Vital Bone Formation, | shows the amount of new bone formed after the procedure | Posted | Mean | Standard Deviation | percentage of vital bone | 16 weeks |
|
16 weeks
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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 | BioOss Collagen | no adverse events were observed | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Palaiologou-Gallis , DDS., MS | UT Health San Antonio (UTHSA), San Antonio, Texas | 210-450 8736 | PalaiologouA@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 24, 2019 | Nov 3, 2025 | Prot_SAP_000.pdf |
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| Bio-Oss® Collagen | Device | 90% bovine derived xenograft granules and 10% porcine collagen |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percent Residual Graft Material | shows how much of the graft material remained intact | Posted | Mean | Standard Deviation | percentage of residual graft | 16 weeks |
|
|
|
| Primary | Percent Fibrous Tissue and Marrow Space | amount of tissue that is neither native bone or graft material | Posted | Mean | Standard Deviation | percentage of marrow | 16 weeks |
|
|
|
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | OSSIX™ Bone | no subject suffered any adverse event due to the materials tested | 0 | 21 | 0 | 21 | 0 | 21 |
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