Alveolar Bone Loss Clinical Trial
Official title:
Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to
examine histologic wound healing following ridge preservation using bone allograft that has
been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire
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 a cancellous non-freeze-dried bone allograft (called PUROS graft). This test
group will be compared to an active control group using cancellous freeze-dried bone
allograft (called FDBA). The null hypothesis is that there will be no significant difference
in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth
extraction, the graft material will be placed and covered by a resorbable collagen membrane.
Following 3 months of healing, the dental implant will be place, at which time a core of bone
will be removed from the site as part of the preparation for the implant. 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
cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a
solvent-based processing method (PUROS). This entire 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 a cancellous
non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an
active control group using cancellous freeze-dried bone allograft (called FDBA). The null
hypothesis is that there will be no significant difference in formation of new vital bone
between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth
extraction, the graft material will be placed and covered by a resorbable collagen membrane.
Following 3 months of healing, the dental implant will be place, at which time a core of bone
will be removed from the site as part of the preparation for the implant. 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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