Objective: To determine if there is a dose-response curve for TGF-beta1 in a rabbit calvarial defect model.

Study Design: Controlled animal study using arms of increasing concentrations of TGF-beta1 to evaluate the osteoinductive potential of each arm.

Methods: Sixteen skeletally mature New Zealand white rabbits were randomized into control and experimental arms. Incremental doses of TGF-beta1 delivered in an inactivated guanidine-extracted demineralized bone matrix (Gu-DBM) carrier were implanted into a critically sized calvarial defect. The animals were sacrificed at 4 weeks and histomorphometric analysis was then accomplished.

Results: TGF-beta1 showed a dose-response relationship, with the higher doses chosen for this study causing more robust osteoinduction.

Conclusions: In this pilot dosing study, TGF-beta1 demonstrates increasing osteoinduction with increasing dose levels in this animal model.

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