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The purpose of this study is to compare the speed of bone healing of the two most commonly used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge preservation model in participants scheduled for tooth extraction and subsequent receipt of a dental implant. Researchers hypothesize that there will be additional vital bone at 16-20 weeks with Salvin-Oss®.
This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to placement of a dental implant. Extraction sites that are not grafted for ridge preservation may lose up to 50 percent of their ridge width the first year after extraction. Xenografts are one of several products on the market used to maintain ridge width after tooth extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of non-molar teeth.
The primary objective of this study is to histologically evaluate and compare the percentage of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss® versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and ridge width after grafting with these two materials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Oss® | Active Comparator | Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). |
|
| Salvin-Oss® | Active Comparator | Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-Oss® | Device | Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction. | Baseline to 16-20 weeks |
| New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks | The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported | Baseline to 16-20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Font, DDS, MS | University of Colorado, Denver | Principal Investigator |
| Charles A Powell, DDS, MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Dental Medicine | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bio-Oss® | Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
| FG001 | Salvin-Oss® | Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Detailed demographics data was not collected for any participant for this study beyond what was required to be verified to confirm study eligibility.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bio-Oss® | Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | More specific age demographics information was not collected for any participant. |
| 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 | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction. | Only participants that completed the study are included in the analysis. | Posted | Mean | Full Range | Percent | Baseline to 16-20 weeks |
|
20 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 | Bio-Oss® | Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kerri Font, DDS, MS | University of Colorado Denver | Anschutz | 303-724-1111 | clinicalresearchsupportcenter@ucdenver.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 | Sep 15, 2021 | Oct 12, 2021 | Prot_SAP_000.pdf |
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Patients will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes.
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Participants will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes. The outcome assessor for histological samples will not be aware of which group the participant was in until code unlocked.
| Salvin-Oss® | Device | Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
|
| Salvin-Oss® |
Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Sex/Gender demographics information was not collected for any participant. | 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 |
|
| OG001 |
| Salvin-Oss® |
Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. |
|
|
| Primary | New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks | The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported | Only participants that completed the study are included in the analysis. | Posted | Mean | Full Range | Percent | Baseline to 16-20 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Salvin-Oss® | Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. | 0 | 18 | 0 | 18 | 0 | 18 |
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