University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
NCT Number: NCT06173791
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.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
San Antonio, Texas, 78229, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bone Allograft fibers used in dental sinus reconstruction surgery
Other names: Demineralized Freeze Dried Bone Allograft Fibers
Bone Allograft particles used in dental sinus reconstruction surgery
Other names: Demineralized Freeze Dried Bone Allograft Particles
DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.
Other names: Deproteinized Bovine Bone Mineral
Time frame: Baseline to 6 months
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.
The University of Texas Health Science Center at San Antonio
Other
Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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