USE OF SMALL INTESTINAL SUBMUCOSE FOR TISSUE REGENERATION IN MAXILLOFACIAL SURGERY A SAFETY STUDY

Abstract

Small intestinal submucosa (SIS) is a promising material for guided tissue regeneration (CTR). Clinical and in vitro experiments within other fields of regenerative surgery had shown high efficiency and biocompatibility. No clinical trials had been developed for oral reconstructive surgery. The objective of this study was to evaluate the safety of new standardized SIS production method as a biomaterial for GTR in maxillofacial surgery. Methods: SIS membranes were produced by a standardized method developed by our research group. Patients with oral defects requiring bone grafting were recruited and treated using autologous bone grafts and SIS membranes. Informed consent was obtained from all patients. Clinic and radiographic data were recorded for each patient pre and post operatively. In vitro cells culture was performed using SIS matrix and fibroblasts prior clinical use to measure biocompatibility. Immune systemic response was evaluated through acute systemic toxicity, pyrogenicity and allergic tests. Results: 49 patients were treated. Age ranged between 21 and 74 years. 37 patients had atrophic bone defects, 7 had infectious bone defects, 2 had traumatic bone defects and 1 had bone defect after mechanical distractor device placement. Optimal clinical and radiographic results were found in response to the surgical treatment. Only two patients showed complications related with dental implants placement after CTR but these complications could not be associated with the use of SIS. As a conclusion SIS showed to be a highly biocornpatible material, adverse reactions to SIS were not found in any case.