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

Abstract

OBJECTIVES: The 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 METHODS: M101 gel and solution (1&#x2009;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&#x2009;weeks. In dogs, peri-implantitis was treated by non-surgical and surgical approaches with or without M101 gel application. Analyses were performed after 2&#x2009;months. Socket healing was evaluated by micro-CT after tooth extraction. Local and systemic responses were evaluated after gel administration and intravenous injection. RESULTS: The cytocompatibility of M101 was confirmed in osteoblasts, and ALP, Runx2, and BMP-2 gene expression was increased after exposure (p&#x2009;<&#x2009;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&#x2009;<&#x2009;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&#x2009;<&#x2009;0.05) when compared to non-surgical treatment without M101 gel. No difference was observed when used as an adjunct to surgical treatment. CONCLUSION: M101 may be a safe and interesting candidate as an adjuvant to improve bone healing and non-surgical treatment in peri-implantitis.