title: Novel calcium sulfate space-making devices for bone regeneration: a pilot study.
abstract: The feasibility of using preformed calcium sulfate (CS) space-making devices (SMDs) for bone regeneration was explored using a rabbit calvarial model. Twenty-four CS devices were fabricated. Twelve of these were SMDs, which consisted of a domed head that served as the actual space-maker, and a stalk or "tail" portion used to affix the device to the bone. A second set of control devices (CDs) was fabricated that consisted of only the tail portion. CDs were made of medical-grade CS, as were 9 of the SMDs. Six of the CS SMDs were loaded with high or low concentrations of simvastatin. The remaining 3 SMDs were made of a CS/bioactive glass composite. One SMD and 1 CD were implanted bilaterally in the parietal bones of 12 New Zealand White rabbits, which were euthanized 8 weeks following surgery. All implants were well tolerated. In all animals, the side receiving the SMD exhibited greater thickness than did the control sites. The addition of simvastatin resulted in a statistically significant difference in calvarial thickness. The CS/bioactive glass composite also yielded encouraging results. The CS resorbable SMDs are worthy of further investigation.
authors.affiliation: Department of Oral Health Practice, University of Kentucky College of Dentistry, Lexington, KY, USA. mvthom0@uky.edu
authors.forename: Mark V
authors.initials: MV
authors.lastname: Thomas
authors.forename: J
authors.initials: J
authors.lastname: Clemens
authors.forename: David A
authors.initials: DA
authors.lastname: Puleo
mesh_terms: D000818:Animals; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D001861:Bone Regeneration; D002133:Calcium Sulfate / Q000627:therapeutic use*; D005260:Female; D010294:Parietal Bone / Q000254:growth & development* / Q000601:surgery; D010865:Pilot Projects; D019736:Prostheses and Implants; D011817:Rabbits; D019821:Simvastatin / Q000627:therapeutic use
chemical_list: D000924:Anticholesteremic Agents; D019821:Simvastatin; D002133:Calcium Sulfate