ABSTRACT
BACKGROUND: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. METHODS: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. RESULTS: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26 ± 17.24 in the study group and 18.27 ± 17.60 in the control group (p = 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p = 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p = 0.515). CONCLUSION: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.
ABSTRACT
BACKGROUND: The primary objectives of mandibular surgery are to achieve optimal occlusion, low sensory disturbance, and adequate fixation with early movement. In-depth knowledge of the mandibular structure is required to achieve these goals. This study used computed tomography (CT) to evaluate the mandibular cortical thickness and cancellous space according to age and sex. METHODS: We enrolled 230 consecutive patients, aged 20 to 50 years, who underwent CT scanning. The cortex and cancellous space centered around the inferior alveolar nerve (IAN) canal were measured at two specific locations: the lingula and second molar region. Statistical analysis of differences according to increasing age and sex was performed. RESULTS: The t-test revealed that the cancellous space and cortical thickness differed significantly with respect to the threshold of 35 years of age. Both cortical thickness and cancellous space in the molar region were negatively correlated with age. Meanwhile, both cortical thickness and cancellous space in the lingula region showed a positive correlation with age. With respect to sex, significant differences in the cancellous space at the molar region and the cortical thickness at the lingula were observed. However, no further statistically significant differences were observed in other variables with respect to sex. The sum of each measurement on the mandibular body reflected the safe distance from the surface of the outer cortex to the IAN canal. The safe distances also showed statistically significant differences between those above and below 35 years of age. CONCLUSION: Knowledge of the anatomical structure of the mandible and of changes in bone structure is crucial to ensure optimal surgical outcomes and avoid damage to the IAN. CT examination is useful to identify changes in the bone structure, and these should be taken into account in the planning of surgery for older patients.
