OSTEOTRANS MX® (Takiron Co., Ltd., Osaka, Japan) is a bioactive resorbable maxillofacial osteosynthetic material composed of an unsintered hydroxyapatite/poly-l-lactide composite, and its effective osteoconductive capacity has been previously documented. However, the mechanical strength of this plate system is unclear. Thus, the aim of this in vitro study was to assess its tensile and shear strength and evaluate the biomechanical intensity of different osteosynthesis plate designs after sagittal split ramus osteotomy by simulating masticatory forces in a clinical setting. For tensile and shear strength analyses, three mechanical strength measurement samples were prepared by fixing unsintered hydroxyapatite/poly-l-lactide composed plates to polycarbonate skeletal models. Regarding biomechanical loading evaluation, 12 mandibular replicas were used and divided into four groups for sagittal split ramus osteotomy fixation. Each sample was secured in a jig and subjected to vertical load on the first molar teeth. Regarding shear strength, the novel-shaped unsintered hydroxyapatite/poly-l-lactide plate had significantly high intensity. Upon biomechanical loading evaluation, this plate system also displayed significantly high stability in addition to bioactivity, with no observed plate fracture. Thus, we have clearly demonstrated the efficacy of this plate system using an in vitro model of bilateral sagittal split ramus osteotomy of the mandible.
Keywords: ">l-lactide composite plate; bioactive resorbable plate; biomechanical loading evaluation; sagittal split ramus osteotomy; tensile and shear strength evaluation; unsintered hydroxyapatite/poly-.