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The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM.
The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFDBA Fibers with DBBM | Active Comparator | After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla. |
|
| DFDBA Particles with DBBM | Other | After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFDBA fibers | Device | Bone Allograft fibers used in dental sinus reconstruction surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Vital Bone Formation | Each side of the maxillary sinus will be used as a separate unit of analysis. The assumption is that each patient will have only one side of the maxillary sinus; however, it is common for some patients to need both maxillary sinuses augmented (2 sites in a single patient). Change in vital bone formation will be measured from baseline (surgery) to 6 months post surgery. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Palaiologou-Gallis, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
All collected de-identified Individual Participant data (IPD) that underlie results in a publication
When summary data are published or otherwise made available
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques
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Only investigators will know which material was used for the sinus lift.
| DFDBA particles | Device | Bone Allograft particles used in dental sinus reconstruction surgery |
|
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| DBBM | Device | DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth. |
|
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |