APANK-Study: Application of autogenous platelet-rich fibrin membranes in the treatment of antiresorptive-associated necrosis of the jaw - a multicenter observational study

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Synthetic analoga of pyrophosphat (bisphosphonates), monoclonal Receptor Activator of Nuclear Factor Kappa b Ligand (RANKL)-antibodies or anti-angiogenetic antibodies are used in the therapy of progressed breast and prostate cancer, or multiple myeloma. Since the first description by Marx et al. in 2003, medication-related osteonecrosis of the jaw (MRONJ) is a severe complication of the antiresorptive therapy, which can lead to partial or complete loss of parts of the jaw. The guideline-compatible therapy consists in the surgical removal of the necrotic bone as well as the achievement of a tension-free and saliva-tight wound closure. Despite compliance with all criteria, surgical therapy is associated with a significant rate of postoperative wound healing disorders and therapy failure. It may result in early wound dehiscence with exposed bone or delayed complications may occur weeks or months after the therapy has been carried out. The pathophysiology of complications is not fully understood, it seems than various factors of wound healing are affected (collagen synthesis, collagen crosslinking, angiogenesis, proliferation of fibroblasts). The additional application of autogenous products, such as the platelet rich fibrin (PRF) membrane, could appear useful as an additive agent in the surgical therapy of MRONJ, as it contains a high concentration of growth factors and matrix components.The aim of the proposed multicenter study is to observe the reduction of post-surgical wound healing complication by application of autogenous PRF-membranes. It is envisaged to include 23 patients per center (n = 46) for a total duration of 12 months. The primary outcome is clinical success (completed wound healing without bone exposure after 6 weeks), which will be determined using two different wound healing scores. The hypothesis is that the additional application of PRF-membranes in the treatment of MRONJ leads to better wound healing within the first six weeks. This pilot study is supposed to gain the prerequisites to subsequently conduct a randomized controlled intervention study that will proof the effectiveness of PRF-membranes in the treatment of medication-related osteonecrosis of the jaw.