Alveolar Bone Loss Clinical Trial
Official title:
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to
examine histologic wound healing following ridge preservation using cortical bone allograft,
cancellous bone allograft, or a combination of both cortical and cancellous bone allograft.
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 combination of 50% cortical/50% cancellous FDBA. This
test group will be compared to two active control groups - one using 100% cortical FDBA and
the other using 100% cancellous 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 non-resorbable membrane.
Following 18-20 weeks 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
cortical bone allograft, cancellous bone allograft, or a combination of both cortical and
cancellous bone allograft. This entire protocol involves procedures that are standard care.
All materials are FDA-approved materials being used in an FDA-approved manner. The study is
a 3-arm, parallel-design, randomized, prospective clinical trial. The test group subjects
will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA.
This test group will be compared to two active control groups - one using 100% cortical FDBA
and the other using 100% cancellous 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 non-resorbable membrane.
Following 18-20 weeks 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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