Evaluation of a Gel Loaded With M101 on Bone and Peri‐Implantitis Healing: An Experimental In Vivo Study

Abstract

ObjectivesThe aim of this study was to evaluate the effect of M101 gel in bone and peri‐implantitis healing and its safety of use.Materials and MethodsM101 gel and solution (1 g/L) were evaluated in four different models: (i) human osteoblast culture; (ii) mouse calvarial defect; (iii) extraction model in dogs; (iv) peri‐implantitis model in dogs. M101 cytocompatibility was evaluated in osteoblasts, and expression of ALP, Runx2, and BMP‐2 was determined. Calvarial defect was induced in mice by bone drilling, and healing was evaluated after 5 weeks. In dogs, peri‐implantitis was treated by non‐surgical and surgical approaches with or without M101 gel application. Analyses were performed after 2 months. Socket healing was evaluated by micro‐CT after tooth extraction. Local and systemic responses were evaluated after gel administration and intravenous injection.ResultsThe cytocompatibility of M101 was confirmed in osteoblasts, and ALP, Runx2, and BMP‐2 gene expression was increased after exposure (p < 0.05). In mice, calvarial bone defect healing was 1.6 folds more in the M101 gel treated group than in the untreated group (p < 0.001). In the extraction model, the local M101 gel application and systemic M101 administration did not induce an immunological response. In the peri‐implantitis dog model, M101 gel as an adjuvant to non‐surgical treatment led to improved PiPD reduction (p < 0.05) when compared to non‐surgical treatment without M101 gel. No difference was observed when used as an adjunct to surgical treatment.ConclusionM101 may be a safe and interesting candidate as an adjuvant to improve bone healing and non‐surgical treatment in peri‐implantitis.