Quality and Quantity of Bone Regeneration in Maxillary Sinus Using Osteocel, Radiographic and Histomorphometric Randomized Controlled Clinical Study

Purpose: The purpose of this study is to histologically and radiographically evaluate the maxillary sinus bone volume and density, with reference to percentage of vital bone present, after 4 months of grafting with either Osteocel plus or a cortical-cancellous allograft. Study Design: Eligible patients will be randomly assigned into one of two treatment groups using a randomization table generated by a computer. The test group (10 sinuses) will receive Osteocel Plus and control group (10 sinuses) will receive conventional cortical-cancellous particulate allograft material. The objective of this research is to serve as a pilot study, gathering information that will guide the design of a larger subsequent study. Little is known about the distribution of bone quality changes in patients who receive Osteocel Plus graft to augment the maxillary sinus. Ten subjects per group is reasonable for a pilot study, providing an 89% probability of estimating the true mean for bone quality and implant stability to within half a standard deviation in each group. These means, along with the observed standard deviations and within-subject correlations that we obtain will prove essential for designing the larger, confirmatory study that constitute the next phase of this research.