Functional Evaluation of a Novel Multi-Axial Alveolar Distractor—Preliminary In Vivo Animal Study

Abstract
This study evaluates the biomechanical performance of a new multi-axial alveolar distractor using an animal study. The multi-axial alveolar distractor is designed with a ball and socket joint mechanism that can rotate up to 60° toward the buccal/lingual and mesial/distal sides intra-operatively to achieve vector control. The transport segment can be moved through activating the transport screw with 0.25 pitch, allowing 13 mm in distraction height. This distractor was fixed at the right angulus mandibular of experimental rabbits and adjusted 15° toward the mesial side and 25° toward the buccal side as Group TMB (toward mesial-buccal) (n = 3), and 15° toward the mesial side as Group TM (toward mesial) (n = 3). Group TC (control) was the control group. The distractors were activated 1 mm/day for 13 days. Living bone growth was observed at various periods. The total bone growth length at the angulus region and buccal side distraction thickness after distraction were calculated. The variations in bone growth geometric shape at the mandible angulus were also recorded. Fracture testing was performed to understand the variations in the mechanical strength between the distracted and intact bone specimens. The digital radiography results showed that the osteotomy areas at the mandible angulus were healed and the bone growth completed after surgery. The average bone growth length of Group TMB was 17.68 mm. This was greater than that of Group TM at 14.79 mm. The corresponding buccal side distractor thicknesses for Group TMB and TM after distraction were 5.12 ± 0.52 mm and 3.32 ± 0.37 mm, respectively. The tensile strengths of the bone specimens after distraction of Groups TMB, TM and TC were 172.13 N, 119.27 N and 304.24 N, respectively, and the percentage of distraction bone tensile strength to normal bone was 57% and 39% for Groups TMB and TM, respectively. This study concluded that this new multi-axial alveolar bone distractor can drive bones to grow in accordance with the direction/angle of the distraction plan. The bone growth healed gradually and presented insufficient mechanical strength.